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

Model Number W4TR01

Device Problem Failure to Interrogate (1332)

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

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that abnormal telemetry with the cardiac resynchronization therapy pacemaker (crt-p) and a possible lead disruption were noted post-coronary artery bypass graft surgery.The device and lead remain in use.No patient complications have been reported as a result of this event.

• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8425937
• MDR Text Key: 138973233
• Report Number: 3004209178-2019-05390
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2019
• Device Model Number: W4TR01
• Device Catalogue Number: W4TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 03/15/2019
• Date Device Manufactured: 10/31/2017
• 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: 5076-52 LEAD, 429888 LEAD, 5076-58 LEAD
• Patient Age: 78 YR