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

Model Number	429678
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical device: 5076 lead implanted (b)(6) 2016.Product event summary: the full lead was returned and analyzed and the outer insulation of the lead was extrinsically breached due to a cut.Visual analysis of the lead indicated apparent explant damage.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) system was removed due to infection.When the pocket was opened, it was discovered that the left ventricular (lv) lead had fractured and broken insulation was observed.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN ABILITY PLUS
• 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: 6780582
• Report Number: 2649622-2017-08373
• Device Sequence Number: 10815543
• Product Code: OJX
• UDI-Device Identifier: 00643169601789
• UDI-Public: 00643169601789
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P080006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2017

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: 02/13/2019
• Device Model Number: 429678
• Device Catalogue Number: 429678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 87 YR