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

Model Number 459888

Device Problems Failure to Capture (1081); Loose or Intermittent Connection (1371); Difficult to Remove (1528); High Capture Threshold (3266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

The full lead was returned and analyzed.No anomalies were found.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient received high voltage therapy for paroxysmal atrial fibrillation (af) with rapid ventricular response that accelerated to ventricular tachycardia (vt).It was also reported that the left ventricular (lv) lead exhibited high threshold and no capture.A revision procedure was scheduled.It was also reported that during the procedure, a left ventricular setscrew problem was noted on the cardiac resynchronization therapy defibrillator (crt-d) that caused the lv lead to be lose inside the header.During the lv explant, extraction difficulty was encountered.The physician used a locking stylet and the lead was successfully removed.A new lv lead was implanted.The crt-d was explanted and replaced.No further patient complications have been reported as a result of this event.

• 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: 10551255
• MDR Text Key: 207493660
• Report Number: 2649622-2020-17894
• 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: Physician
• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2018
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR