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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 4543 lead, implant date unknown; product id: 0185 lead, implant date unknown; product id: 4136 lead, implant date unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the cardiac resynchronization therapy pacemaker (crt-p) changeout procedure, after successfully connecting the existing competitor lead to the new device without issue, the physician determined the lead was not fully seated in the header.The lead was unscrewed and repositioned within the header.Upon multiple attempts to engage and tighten the set screw with multiple wrenches the physician was unable to re-secure the lead within the header.The physician then removed the grommet and attempted to tighten the setscrew, and was still unable.Finally the physician removed the setscrew and successfully used a new one without consequence.The lead was tested and a good connection with the device was confirmed.Medical adhesive was used at the site of the set screw to fill in the place where the grommet had been.The device is still in use.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 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11467410
• MDR Text Key: 239430073
• Report Number: 9614453-2021-00994
• 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: 03/11/2021

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: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: W1TR01
• Device Catalogue Number: W1TR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/11/2021
• Date Device Manufactured: 11/12/2020
• 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 Age: 68 YR