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

Model Number	419578
Medical Device Problem Code	Capturing Problem (2891)
Health Effect - Clinical Codes	Muscle Stimulation (1412); Dyspnea (1816)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 693565 lead implanted: (b)(6) 2010; 383059 lead implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the left ventricular (lv) lead displayed increased thresholds which affected the battery life of the cardiac resynch ronization therapy defibrillator (crt-d).The lv lead was inactivated however the patient experienced dyspnea on exertion and the lead was turned back on.It was further reported there was chronic left diaphragmatic stimulation.As the stimulation did not bother the patient, only the generator change was performed due to elective replacement indicator (eri).The lead remains in use and the device was explanted and replaced.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 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: 7671016
• Report Number: 2649622-2018-11076
• Device Sequence Number: 10989533
• Product Code: OJX
• UDI-Device Identifier: 00885074511986
• UDI-Public: 00885074511986
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P060039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: 10/22/2010
• Device Model Number: 419578
• Device Catalogue Number: 419578
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: DTBA1D1 CRTD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR