Astra, Azure (XT SR, XT DR, S SR, S DR) MRI SureScan, Percepta, Serena, Solara (Quad CRT-P, CRT-P) MRI Sure Scan (2019-05-06)
- Starting date:
- May 6, 2019
- Posting date:
- May 24, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-70025
Last updated: 2019-05-24
Affected Products
- Astra XT SR MRI SureScan
- Astra XT DR MRI SureScan
- Astra S SR MRI SureScan
- Astra S DR MRI SureScan
- Azure XT SR MRI SureScan
- Azure XT DR MRI SureScan
- Azure S DR MRI SureScan
- Azure S SR MRI SureScan
- Percepta CRT-P MRI SureScan
- Percepta Quad CRT-P MRI SureScan
- Serena CRT-P MRI SureScan
- Serena Quad CRT-P MRI SureScan
- Solara CRT-P MRI SureScan
- Solara Quad CRT-P MRI SureScan
Reason
Medtronic has identified a rare but potentially serious failure mode in a population of Azure and Astra pacemakers, and Percepta, Serena and Solara cardiac resynchronization therapy pacemakers (CRT-P), manufactured with a specific multilayer ceramic capacitor. As of April 26, 2019, three complaints out of ~266,700 devices distributed worldwide since February 2017, have been received that included a no output /no telemetry scenario resulting from rapid battery depletion. Battery depletion due to this issue can range from several days to several weeks. One of these reported events contributed to a patient death. The three confirmed failures occurred within 9 months post implant. The projected rate for this issue is 0.0028%, with the most susceptible period for a leakage pathway to develop in the capacitor being the first 12 months post implant. Upon further analysis at the Medtronic Product Analysis Lab (PAL), it was determined that the device failures were both caused by a cracked XC342 (C12) capacitor. If a crack in the ceramic capacitor, along with humidity and bias, results in silver migration that creates a leakage path, the battery is at risk of becoming depleted without warning to the patient.
Affected products
A. Astra XT SR MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
X2SR01
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
B. Astra XT DR MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
X2DR01
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
C. Astra S SR MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
X3SR01
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
D. Astra S DR MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
X3DR01
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
E. Azure XT SR MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
W2SR01
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
F. Azure XT DR MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
W2DR01
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
G. Azure S DR MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
W3DR01
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
H. Azure S SR MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
W3SR01
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
I. Percepta CRT-P MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
W1TR04
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
J. Percepta Quad CRT-P MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
W4TR04
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
K. Serena CRT-P MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
W1TR05
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
L. Serena Quad CRT-P MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
W4TR05
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
M. Solara CRT-P MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
W1TR06
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
N. Solara Quad CRT-P MRI SureScan
Lot or serial number
Not applicable.
Model or catalog number
W4TR06
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES