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

Model Number	439878
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during a routine upgrade procedure from an implantable pulse generator (ipg) to cardiac resynchronization therapy defibrillator (crt-d), the patient experienced a coronary sinus (cs) dissection.The left ventricular lead was not used and another was implanted about 18 days later.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary : the full lead was returned, analyzed, and no anomalies were found.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: 8276069
• Report Number: 2649622-2019-01321
• Device Sequence Number: 19147270
• Product Code: OJX
• UDI-Device Identifier: 00643169002487
• UDI-Public: 00643169002487
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2017
• Device Model Number: 439878
• Device Catalogue Number: 439878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/07/2019
• 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: 5076-45 LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR