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

Model Number C6TR01

Device Problems Premature Discharge of Battery (1057); Mechanical Problem (1384)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant products : 1488t x2 leads implanted (b)(6) 2002, tissue valve implanted (b)(6) 1996.

Event Description

It was reported by the patient that the patient could see "wires poking out of the side of the device." it was also reported by the patient that two recent battery longevity estimates were three years and then one year, when the interrogations were only three months apart.Follow-up with the physician's office was attempted, but no information could be obtained.No patient complications have been reported as a result of this event.

• Brand Name: VIVA XT 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7092235
• MDR Text Key: 94211426
• Report Number: 9614453-2017-04257
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2016
• Device Model Number: C6TR01
• Device Catalogue Number: C6TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2017
• Date Device Manufactured: 05/29/2015
• 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
• Patient Age: 45 YR