MAUDE Adverse Event Report: MEDTRONIC, INC. IS-1 UNI LEAD TO IS-1 UNI IPG - PERMANENT LEAD EXTENSION KIT; ADAPTOR, LEAD, PACEMAKER

Model Number	6981M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4965-15 lead, implanted: (b)(6) 2002; 4965-25 lead, implanted: (b)(6) 2004; 6981m adaptor/extender, implanted: (b)(6) 2006.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right atrial (ra) lead was implanted using a lead extender.There was a fracture noted in either the lead or the extender, it was not able to be determined where the fracture occurred.The extender and lead were initially programmed off, then capped, and the lead was replaced.No patient complications have been reported as a result of this event.

• Brand Name: IS-1 UNI LEAD TO IS-1 UNI IPG - PERMANENT LEAD EXTENSION KIT
• Common Device Name: ADAPTOR, LEAD, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8231940
• Report Number: 2182208-2019-00058
• Device Sequence Number: 16549467
• Product Code: DTD
• UDI-Device Identifier: 00681490153553
• UDI-Public: 00681490153553
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K911827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 10/14/2008
• Device Model Number: 6981M
• Device Catalogue Number: 6981M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/09/2019
• 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: ADDR01 IPG
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 20 YR
• Patient Weight: 64