MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPTA QUAD CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W4TR01

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 407652, lead, implanted: (b)(6) 2009.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported by the patient that the cardiac resynchronization therapy defibrillator (crt-d) exhibited no telemetry when using their remote monitor.The device remains in use.No patient complications have been reported as a result of this event.

• Brand Name: PERCEPTA QUAD CRT-P MRI SURESCAN
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10906485
• MDR Text Key: 228601148
• Report Number: 3004209178-2020-20662
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2018
• Device Model Number: W4TR01
• Device Catalogue Number: W4TR01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Date Device Manufactured: 06/04/2017
• 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 Age: 86 YR