MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PERCEPTA CRT-P MRI SURESCAN; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number W1TR01

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 4968-35 lead (x2), implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right atrial (ra) lead exhibited noise due to possible fracture.The lead was capped and replaced.Noise was subsequently observed on the right ventricular (rv) lead later that day due to possible fracture.The patient was taken back to the operating room the next day.The physician had difficulty unscrewing and rescrewing the rv setscrew back into the cardiac resynchronization therapy pacemaker (crt-p) header.Once the lead was thought to be secured, the noise was no longer present.The lead had been tested with an analyzer and via manual manipulation and all electrical measurements were appropriate.The patient was kept overnight for observation and the noise was observed again on the rv lead the following morning.The lead was then capped and replaced.The crt-p was explanted and replaced due to the header issues the day before.No patient complications have been reported as a result of this event.

• Brand Name: PERCEPTA CRT-P MRI SURESCAN
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10480626
• MDR Text Key: 205244412
• Report Number: 9614453-2020-02692
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00643169891401
• UDI-Public: 00643169891401
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2021
• Device Model Number: W1TR01
• Device Catalogue Number: W1TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2020
• Date Device Manufactured: 06/23/2020
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 18 YR