MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA ATTAIN STARFIX LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number	419588
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoxia (1918); Memory Loss/Impairment (1958); Pain (1994); Brain Injury (2219); Cardiac Tamponade (2226); Vascular Dissection (3160)
Date of Event	11/07/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Continuation of d10: dtba1d4 crt-d implant: date (b)(6) 2017.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the patient is deceased.It was alleged that the active fixation lobes of the lead promoted aggressive scar tissue growth that made extraction unusually difficult and dangerous.The lv lead lobes of the lead did not retract as designed.The lobes ultimately caused a coronary sinus tear resulting in cardiac tamponade, which resulted in emergency surgical repair via sternotomy and cardiopulmonary bypass.The patient suffered oxygen deprivation for approximate 25-30 minutes, resulting in permanent brain damage, short term memory loss, physical pain, and other serious injuries.The lv lead was implanted for approximately ten years prior to explant.The left ventricular (lv) lead was explanted approximately two years prior to the patient's death.

• Brand Name: ATTAIN STARFIX LEAD
• Common Device Name: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 23478215
• Report Number: 2649622-2025-31107
• Device Sequence Number: 18705212
• Product Code: OJX
• UDI-Device Identifier: 00885074511955
• UDI-Public: (01)00885074511955(17)140828
• 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: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: 08/28/2014
• Device Model Number: 419588
• Device Catalogue Number: 419588
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/05/2025
• Date Device Manufactured: 03/27/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 6947M62 LEAD, 5076-52 LEAD.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 51 YR
• Patient Sex: Male