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

Model Number 407658

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

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

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: w3dr01 ipg; implanted (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that post-implant the right ventricular (rv) lead exhibited undefined bipolar and unipolar impedance qualified as high, and high thresholds.An x-ray was performed and the rv lead connector pin was observed to not be all the way through connector block.The pocket was opened and the implantable pulse generator (ipg) setscrew did not feel right.The ipg was explanted and replaced.The rv lead remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated pacing capture threshold in the right ventricle was elevated.If information is provided in the future, a supplemental report will be issued.

• 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: 9796673
• MDR Text Key: 182288180
• Report Number: 2649622-2020-04625
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00643169708204
• UDI-Public: 00643169708204
• 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,Followup
• Report Date: 03/18/2020

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: 09/28/2021
• Device Model Number: 407658
• Device Catalogue Number: 407658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2019
• 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: 407652 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR