MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number C6TR01

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the cardiac resynchronization therapy pacemaker (crt-p) battery was depleting very rapidly.High lead outputs were also observed on the pacing lead implanted in the his bundle and output was increased to an even higher level.The crt-p and lead remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIVA CRT-P
• Type of Device: PULSE 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9272356
• MDR Text Key: 164854772
• Report Number: 9614453-2019-03711
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169351905
• UDI-Public: 00643169351905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2018
• Device Model Number: C6TR01
• Device Catalogue Number: C6TR01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 383069 LEAD, 5076-52 LEAD, 5076-58 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR