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

Model Number	6984M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products - model: 506852, lead; implanted: (b)(6) 1999, model: d314drg, implantable cardioverter defibrillator (icd); implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that erosion occurred.It was unknown if the erosion was due to the lead or the lead extender.The implantable cardioverter defibrillator (icd) system was explanted and replaced with a pacing system as the patient no longer met criteria for a tachy device.No further patient complications have been reported as a result of this event.

• Brand Name: IS-1 BI LEAD TO IS-1 BI 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: 8578693
• Report Number: 2182208-2019-00836
• Device Sequence Number: 1537499
• Product Code: DTD
• UDI-Device Identifier: 00681490153621
• UDI-Public: 00681490153621
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K915724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/14/2005
• Device Model Number: 6984M
• Device Catalogue Number: 6984M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 05/03/2019
• 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: 4968-25, LEAD / 6721S-50, LEAD / 6721M-50, LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR