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

Model Number W1TR04

Device Problems Premature Discharge of Battery (1057); Inappropriate or Unexpected Reset (2959)

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

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was questioned whether there was high battery drain due to power on reset (por) and high previous/post outputs.It was noted the device had reached battery depletion prematurely.It was noted there was rising, high and unstable threshold.The device was reprogrammed.The device and leads 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 indicated a full electrical reset.Analysis of the device memory indicated that the atrial and ventricular rate histogram data were missing/invalid.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERCEPTA CRTP
• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8197648
• MDR Text Key: 131466042
• Report Number: 9614453-2018-04546
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2018
• Device Model Number: W1TR04
• Device Catalogue Number: W1TR04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR