MAUDE Adverse Event Report: MPRI CAPSUREFIX MRI SURESCAN; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 5086MRI58

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pocket Stimulation (1463); Low impedance (2285); Electronic Property Issue (2928); High Capture Threshold (3266)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 07/27/2017

Event Type  Injury  

Event Description

It was reported that lead polarity switch caused the patient to experience pocket stimulation.Additionally, there was high thresholds, low impedance and oversensing on the right ventricular (rv) lead.Due to no capture at max output, the patient was permanently reprogrammed to unipolar.The lead remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was below the expected lower range.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSUREFIX MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6925182
• MDR Text Key: 88738683
• Report Number: 2649622-2017-12249
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 00613994657374
• UDI-Public: 00613994657374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090013
• 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: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2013
• Device Model Number: 5086MRI58
• Device Catalogue Number: 5086MRI58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2011
• 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): Required Intervention
• Patient Age: 51 YR