MAUDE Adverse Event Report: MEDTRONIC, INC. HV SPLITTER/ADAPTOR KIT; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	5019
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/31/2019
Type of Reportable Event	Malfunction
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 lead exhibited high impedance and had a possible fracture.It was also reported that the splitter tool had a "possible connector fracture." the lead was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned, analyzed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HV SPLITTER/ADAPTOR KIT
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 9659989
• Report Number: 2182208-2020-00209
• Device Sequence Number: 3363731
• Product Code: LWS
• UDI-Device Identifier: 00613994220288
• UDI-Public: 00613994220288
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: Health Professional
• Device Expiration Date: 12/11/2017
• Device Model Number: 5019
• Device Catalogue Number: 5019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR