MAUDE Adverse Event Report: MEDTRONIC, INC. CAPSURE EPICARDIAL LEAD; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number	4965-15
Medical Device Problem Codes	Failure to Capture (1081); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: addrl1 ipg doi: 29-nov-2011 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 during a generator change out when attempting to connect the right atrial (ra) lead to the replacement implantable pulse generator (ipg) no clicks were audible and the lead was easily pulled out of the header.The lead was taken out of the header, and the set screw was visually confirmed to not be obstructing the port.The lead was then re-inserted into the header while the wrench was held in place to vent any trapped air.Again, no wrench clicks were heard and the lead was not secured.The ipg was removed and replaced.When wrenching the ra lead into the replacement ipg wrench clicks were heard immediately and the lead was secured.A visible fracture was observed at the pin plug junction to the main lead body that had been suspected due to no capture of the atrial lead.The ipg was attempted not used, removed and replaced.The right atrial (ra) lead remains in use for sensing purposes.No patient complications have been reported as a result of this event.

• Brand Name: CAPSURE EPICARDIAL LEAD
• Common Device Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19173886
• Report Number: 2182208-2024-01771
• Device Sequence Number: 18097228
• Product Code: NVN
• UDI-Device Identifier: 00681490116336
• UDI-Public: 00681490116336
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P950024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• 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): 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/14/2008
• Device Model Number: 4965-15
• Device Catalogue Number: 4965-15
• 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: 04/15/2024
• Initial Report FDA Received Date: 04/24/2024
• Date Device Manufactured: 11/03/2006
• 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: 4968-25 LEAD
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 41 KG