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

Model Number	439878
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)
Health Effect - Clinical Code	Muscle Stimulation (1412)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dtba1qq crt-d, implanted: (b)(6) 2016; 6947m55, implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) did not reach expected longevity.The device was explanted and replaced.It was further reported that the left ventricular (lv) lead exhibited high thresholds and caused diaphragmatic stimulation.The lead was reprogrammed and remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN PERFORMA
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8413445
• Report Number: 2649622-2019-04193
• Device Sequence Number: 239486
• Product Code: OJX
• UDI-Device Identifier: 00643169002487
• UDI-Public: 00643169002487
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/18/2017
• Device Model Number: 439878
• Device Catalogue Number: 439878
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5086MRI45 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR