MAUDE Adverse Event Report: MPRI ATTAIN OVER THE WIRE LEAD; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	419388
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use the left ventricular (lv) lead exhibited falling lv pacing impedance.The lv lead was no longer functional, and not deemed necessary for patient.The lv lead was capped and remains in the patient.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: dtmb1d1 crt-d implanted: (b)(6) 2017 2000us vad accessory kit, 1600us vad accessory kit, 1475-vad accessory kit, 1103 vad pump system, 1425us vad accessory kit, 690r28 heart ring, 1425us vad accessory kit, 1125 vad outflow graft, 2050us vad accessory kit, 1435-vad accessory kit implanted: (b)(6) 2015 2050us vad accessory kit implanted: (b)(6) 2015 1475-vad accessory kit implanted: (b)(6) 2016 1425us vad accessory kit implanted: (b)(6) 2016 1440 vad accessory kit implanted: (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.

• Brand Name: ATTAIN OVER THE WIRE LEAD
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19221845
• Report Number: 2649622-2024-12089
• Device Sequence Number: 15188942
• Product Code: LWP
• UDI-Device Identifier: 00885074200736
• UDI-Public: 00885074200736
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P010015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: 04/08/2010
• Device Model Number: 419388
• Device Catalogue Number: 419388
• 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: 04/10/2024
• Initial Report FDA Received Date: 05/01/2024
• Date Device Manufactured: 05/02/2008
• 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: 694765 LEAD, 5076-52 LEAD.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 150 KG