MAUDE Adverse Event Report: MEDTRONIC, INC. PACEMAKER PERCEPTA CRT-P MRI SURESCAN AND PERCEPTA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number W1TR01

Device Problems Failure to Interrogate (1332); Pacing Problem (1439); Product Quality Problem (1506); Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 10/09/2021

Event Type  Injury  

Event Description

This is a (b)(6) male with pmh nonischemic cardiomyopathy, cad, chf with a right sided medtronic percepta crt-p pacemaker under advisory for possible device reset to rv only pacing at 65 bpm for the percepta family of crt pacemakers.He presented to (b)(6) on (b)(6) 2021 after this device abruptly stopped functioning without any backup pacing.At presentation to (b)(6), this device had attempted interrogations by medtronic representatives (b)(4) as well as bsc rep (b)(4); no communication with the device could be established and it was presume there was a catastrophic failure with no backup pacing whatsoever.The patient underwent emergency care with temporary pacing until he recovered and underwent generator change.The device was a medtronic percepta w1tr01, serial number (b)(4).It was returned to the manufacturer via the local medtronic representative on (b)(6) 2021 (day of explantation).Fda safety report id# (b)(4).

• Brand Name: PACEMAKER PERCEPTA CRT-P MRI SURESCAN AND PERCEPTA QUAD CRT-P MRI SURESCAN
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): MEDTRONIC, INC.; minneapolis MN 55432
• MDR Report Key: 12960567
• MDR Text Key: 282003468
• Report Number: MW5105899
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: W1TR01
• Device Catalogue Number: PERCEPTA CRT-P MRI SURESCAN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Hispanic