MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA S MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 459888

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a left ventricular (lv) lead polarity switch occurred a month ago.It was noted that some reprogramming was done, however another polarity switch occurred in the current month.It was also noted that there was invalid data for the event logs on the cardiac resynchronization therapy pacemaker (crt-p).The lv lead and the crt-p remain 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 left ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the left ventricular pacing lead was variable.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN PERFORMA S MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• 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: 8894652
• MDR Text Key: 154322311
• Report Number: 2649622-2019-14339
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601871
• UDI-Public: 00643169601871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/26/2020
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• 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: W4TR03 CRTP, 5076-52 LEAD, 5076-58 LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR