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

Model Number W1TR02

Device Problem Incorrect Measurement (1383)

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

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an incorrect battery voltage measurement on the cardiac resynchronization therapy pacemaker (crt-p).The device was later explanted and replaced unrelated to the incorrect measurement.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Secondary review of the reported event determined that there is improbable risk to the patient associated with this issue.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was an incorrect battery voltage measurement on the cardiac resynchronization therapy pacemaker (crt-p) which did not affect device performance.The device was later explanted and replaced unrelated to the incorrect measurement.No patient complications have been reported as a result of this event.

• Brand Name: SERENA 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: 9832458
• MDR Text Key: 184376846
• Report Number: 3004209178-2020-05378
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169735651
• UDI-Public: 00643169735651
• 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
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/14/2019
• Device Model Number: W1TR02
• Device Catalogue Number: W1TR02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/19/2018
• 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: 72 YR