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

Model Number	429678
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: t510c31, tricuspid valve, implanted: (b)(6) 2016.
Event or Problem Description
It was reported that the left ventricular (lv) lead exhibited high threshold at implant as well as post-operatively.The lead was explanted and replaced with an epicardial lead.No 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 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: 6317211
• Report Number: 2649622-2017-00531
• Device Sequence Number: 1576718
• Product Code: OJX
• UDI-Device Identifier: 00643169601789
• UDI-Public: 00643169601789
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/10/2016

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: 08/02/2018
• Device Model Number: 429678
• Device Catalogue Number: 429678
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: 11/10/2016
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: A2DR01 IPG, S53 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 44 YR