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

Model Number	W4TR03
Medical Device Problem Codes	Failure to Interrogate (1332); Pacing Problem (1439); Battery Problem (2885)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	10/07/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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.

• Brand Name: SOLARA QUAD CRTP
• Common Device Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• MDR Report Key: 8031501
• Report Number: 9614453-2018-03805
• Device Sequence Number: 9999988
• Product Code: NKE
• UDI-Device Identifier: 00643169891456
• UDI-Public: 00643169891456
• Combination Product (Y/N): N
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/28/2019
• Device Model Number: W4TR03
• Device Catalogue Number: W4TR03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4298-88 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR