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

Model Number 407652

Device Problems High impedance (1291); Connection Problem (2900); High Capture Threshold (3266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

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 high thresholds and high impedance due to the setscrew not being tightened on lead pin.The ra lead was removed, reinserted and remains in use.No patient complications have been reported as a result of this event.

• Brand Name: CAPSUREFIX NOVUS 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: 10406751
• MDR Text Key: 202870049
• Report Number: 2649622-2020-15495
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00643169708198
• UDI-Public: 00643169708198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930039
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/05/2022
• Device Model Number: 407652
• Device Catalogue Number: 407652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2020
• Date Device Manufactured: 04/15/2020
• 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
• Treatment: 407658 LEAD, W1DR01 IPG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR