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

Model Number	4965-15
Medical Device Problem Codes	Intermittent Capture (1080); Failure to Capture (1081)
Health Effect - Clinical Codes	Bradycardia (1751); Vomiting (2144); Convulsion/Seizure (4406)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: addr01 ipg, implanted on (b)(6) 2013.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 emergency department with seizure-like symptoms and significant bradycardia.They administered medication to the patient which they did not tolerate very well and was vomiting.It was noted that their pacemaker was not capturing and it was identified that the right ventricular (rv) lead exhibited loss of capture even at the devices maximum programmable outputs.Some intermittent capture was also observed when the patient was lying on their right side.The right ventricular (rv) lead and the remaining system was programmed off and inactivated and will be removed at a later date.A new implantable pulse generator (ipg) system was implanted.No further 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) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 11377242
• Report Number: 2182208-2021-00795
• Device Sequence Number: 19778534
• Product Code: NVN
• UDI-Device Identifier: 00681490116336
• UDI-Public: 00681490116336
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P950024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 03/14/2010
• Device Model Number: 4965-15
• Device Catalogue Number: 4965-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/25/2021
• 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: 4965-25 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 11 YR