MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRTP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W4TR01

Device Problem Reset Problem (3019)

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

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 429888 lead, implanted: (b)(6) 2017.This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the device had a divide by zero reset.The device was interrogated with a programmer containing the firmware update software.The device remains in use.It was also noted that several months prior there had been a lead impedance alert on both the left ventricular lead and the atrial lead for impedance out of range.Both leads remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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 software error.Analysis of the device memory indicated an issue with missing/invalid diagnostic data.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERCEPTA QUAD CRTP
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7864456
• MDR Text Key: 119824594
• Report Number: 3004209178-2018-20335
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735644
• UDI-Public: 00643169735644
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2019
• Device Model Number: W4TR01
• Device Catalogue Number: W4TR01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2413-2018
• Patient Sequence Number: 1
• Treatment: 5076-52 LEAD, 5076-45 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR