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

Model Number	419578
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle Stimulation (1412)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5076-52 lead, implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient presented to the clinic for a device check and diaphragmatic stimulation was observed.The patient noted they had experienced diaphragmatic stimulation since implant of the left ventricular (lv) lead two years prior, however, did not report it to the clinic.The nurse attempted to reprogram the lv lead to alleviate the stimulation to no avail.After review with the physician, it was decided to program the lv lead off.The lv lead remains in-situ.The patient is a participant in the post approval clinical surveillance product surveillance registry.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: 8961905
• Report Number: 2649622-2019-15957
• Device Sequence Number: 2859773
• Product Code: OJX
• UDI-Device Identifier: 00643169590632
• UDI-Public: 00643169590632
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P060039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/25/2018
• 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: 08/20/2019
• Initial Report FDA Received Date: 09/04/2019
• 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: C6TR01 CRT-P, 6725 ADAPTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Weight: 57