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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL SOLARA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

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MEDTRONIC EUROPE SARL SOLARA QUAD CRTP PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION Back to Search Results
Model Number W4TR03
Device Problems Failure to Interrogate (1332); Pacing Problem (1439); Battery Problem (2885)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 10/07/2018
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient went into cardiac arrest/asystole and presented to the emergency room. The cardiac resynchronization therapy pacemaker (crt-p) was unable to be interrogated using multiple programmers. There was no pacing output observed from the device and it was suspected the battery was depleted. It was noted the device did not respond when a magnet was placed on it. Cardioversion was attempted and the patient received cardiopulmonary resuscitation (cpr) while a temporary pacing lead was inserted. The device was scheduled for replacement. It was added the patient was not doing well and placed on life support and the family/physician were leaning towards withdrawing all care going forward. The patient passed away two days later.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed. The returned device indicated leakage in the hybrid. Hybrid analysis determined that the anomalous current drain was due to a faulty c12 capacitor. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSOLARA QUAD CRTP
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key8031501
MDR Text Key125900144
Report Number9614453-2018-03805
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2019
Device Model NumberW4TR03
Device Catalogue NumberW4TR03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/01/2018 Patient Sequence Number: 1
Treatment
4298-88 LEAD, 5076-52 LEAD
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