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

Model Number 459888

Device Problems Electrical /Electronic Property Problem (1198); Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  Injury  

Event Description

It was reported that the cardiac resynchronization therapy pacemaker (crt-p) exhibited invalid data for a false alert for left ventricular (lv) lead impedance measurement that was below the threshold limit, which resulting in a polarity switch.A review of lead trend data confirmed the measurement was within normal limits.However, data also showed there was just one measurement below the threshold resulting in the alert and polarity switch.The device remains in use.The lv lead was reprogrammed back to the previous vector.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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 below the expected lower range.Analysis of the device memory indicated a polarity switch.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) P
• 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: 14030095
• MDR Text Key: 288772202
• Report Number: 2649622-2022-06562
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/09/2023
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Date Device Manufactured: 08/24/2021
• 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: W4TR06 CRTP.
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male