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

Model Number	419578
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: c6tr01 crt-p, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced phrenic nerve stimulation.Additional information reported the left ventricular (lv) lead exhibited high thresholds.The lv lead was capped and replaced.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN STARFIX LEAD
• 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: 9196687
• Report Number: 2649622-2019-18970
• Device Sequence Number: 11550056
• Product Code: OJX
• UDI-Device Identifier: 00885074511986
• UDI-Public: 00885074511986
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P060039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/15/2009
• Device Model Number: 419578
• Device Catalogue Number: 419578
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/16/2019
• 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: 5568-53 LEAD, 5068-58 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 60