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	Impedance Problem (2950)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dtba1d1 crt-d implanted: (b)(6) 2015.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 alerted for an out of range superior vena cava (svc) defibrillation impedance.The patient had complained of chest heaviness and shortness of breath upon exertion.It was additionally reported the lead integrity alert (lia) had triggered.The right atrial (ra) lead and rv lead were reprogrammed.The leads remain in use.The patient is a participant in the world-wide randomized antibiotic envelope infection prevention trial clinical study.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: 7542216
• Report Number: 2182208-2018-00979
• Device Sequence Number: 2435490
• Product Code: DTD
• UDI-Device Identifier: 00681490153621
• UDI-Public: 00681490153621
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K915724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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: 08/20/2017
• 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: 04/30/2018
• Initial Report FDA Received Date: 05/24/2018
• 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: 439688 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 84