MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT

Model Number 5076-45

Device Problems Pacing Problem (1439); Connection Problem (2900)

Patient Problem Syncope (1610)

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-52 lead, implanted (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced multiple episodes of syncope after being discharged from the hospital.A device check noted that the right atrial (ra) lead exhibited pacing failure.It was suspected that there was a connection issue with the implantable pulse generator (ipg).An x-ray confirmed the insertion depth of the right atrial (ra) lead pin was shallow.A revision procedure was performed and the ra lead was reconnected to the ipg.The ra lead and the ipg remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSUREFIX NOVUS LEAD MRI SURESCAN
• Type of Device: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10096794
• MDR Text Key: 193036075
• Report Number: 2649622-2020-10138
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00681490124799
• UDI-Public: 00681490124799
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2013
• Device Model Number: 5076-45
• Device Catalogue Number: 5076-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 05/28/2020
• Date Device Manufactured: 09/09/2011
• 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; Life Threatening; Required Intervention