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

Model Number 429688

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-52 lead; 5076-45 lead, implanted (b)(6) 2001.Product event summary: the partial lead was returned in segments, analyzed, and 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 left ventricular (lv) lead was damaged with a cut by the physician while performing the generator change.The lead was explanted.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY PLUS 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: 10159228
• MDR Text Key: 195291853
• Report Number: 2649622-2020-11387
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00613994719133
• UDI-Public: 00613994719133
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/10/2013
• Device Model Number: 429688
• Device Catalogue Number: 429688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2012
• 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: C4TR01 CRT-P
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR