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	Break (1069); High Capture Threshold (3266)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right ventricular (rv) lead exhibited high thresholds and "insulation stripped when taken out of header".The rv lead was capped and replaced.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) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10654738
• Report Number: 2182208-2020-02290
• Device Sequence Number: 16935931
• Product Code: NVN
• UDI-Device Identifier: 00681490116336
• UDI-Public: 00681490116336
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P950024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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: 02/28/2012
• 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: 09/17/2020
• Initial Report FDA Received Date: 10/09/2020
• 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: C6TR01 CRT-P, 4968-35 LEAD, 4968-35 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR