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

Model Number	419588
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical devices: 305u25 valve, implanted: (b)(6) 2010.
Event or Problem Description
It was reported that during a device follow-up, the left ventricular (lv) lead exhibited loss of capture, along with a high lv pacing threshold.The lv 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 STARFIX
• 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: 6162439
• Report Number: 2649622-2016-15091
• Device Sequence Number: 976043
• Product Code: OJX
• UDI-Device Identifier: 00643169590649
• UDI-Public: 00643169590649
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P060039
• 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): 10/26/2016

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: 05/25/2018
• Device Model Number: 419588
• Device Catalogue Number: 419588
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: 10/26/2016
• Initial Report FDA Received Date: 12/09/2016
• 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: DTBA1D4 DEVICE, 6935M62 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR