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

Model Number	419588
Medical Device Problem Codes	High impedance (1291); Capturing Problem (2891)
Health Effect - Clinical Codes	Dyspnea (1816); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) device interrogation report displayed question marks instead of the threshold value.It was also reported that the crt-d appeared to be occasionally undersensing and/or blanking on atrial lead during atrial tachycardia/atrial fibrillation (af) event(s).The crt-d and the ra lead remains in use.It was also reported that the left ventricular (lv) lead triggered impedance warning lvtip to rvcoil for high undefined impedance.The lv lead remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: dtmb1d4 crt-d implanted: (b)(6) 2020, 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction: b1, b2, b5, h6, additional codes imf (annex f) 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 cardiac resynchronization therapy defibrillator (crt-d) device interrogation report displayed question marks instead of the threshold value.It was also reported that the crt-d appeared to be occasionally undersensing and/or blanking on atrial lead during atrial tachycardia/atrial fibrillation (af) event(s).The crt-d and the ra lead remains in use.It was also reported that the left ventricular (lv) lead triggered impedance warning lvtip to rvcoil for high undefined impedance and possible capture issue noted with patient experience of shortness of breath.The lv lead remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: b5.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 cardiac resynchronization therapy defibrillator (crt-d) device interrogation report displayed question marks instead of the threshold value.  the crt-d remains in use.  it was also reported that the left ventricular (lv) lead triggered impedance warning lvtip to rvcoil for high undefined impedance and possible capture issue noted with patient experience of shortness of breath.  the lv lead remains in use.  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): 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: 23396971
• Report Number: 2649622-2025-30096
• Device Sequence Number: 18637754
• Product Code: OJX
• UDI-Device Identifier: 00885074511955
• UDI-Public: (01)00885074511955(17)150507
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P060039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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: 05/07/2015
• Device Model Number: 419588
• Device Catalogue Number: 419588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 02/06/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 10/28/2025; 02/09/2026
• Date Device Manufactured: 12/20/2013
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 407645 LEAD, 6947M55 LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 55 KG