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

Model Number	5866-38M
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5568-45 lead, implanted on (b)(6) 2001; 452353s lead, implanted on (b)(6) 1994; 6932-65 lead, implanted on (b)(6) 1996.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that high thresholds, high and undefined impedance and noise were noted on the right atrial (ra) leads.It was noted that a previously implanted adapter was fixed to two ra leads and an implantable cardioverter defibrillator (icd).During the change out of the icd, the leads were capped and replaced with one ra lead and the adapter was removed.When doing the battery change of the icd the physician tested the two ra leads and thresholds were within normal limits.Therefore it was concluded that the adapter may be the issue.No patient complications have been reported as a result of this event.

• Brand Name: TWO IS-1 UNI LEADS TO IS-1 BI IPG ADAPTOR KIT
• Common Device Name: ADAPTOR, LEAD, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7883536
• Report Number: 2182208-2018-01702
• Device Sequence Number: 1837281
• Product Code: DTD
• UDI-Device Identifier: 00681490136907
• UDI-Public: 00681490136907
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K911302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2018

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: 02/14/2014
• Device Model Number: 5866-38M
• Device Catalogue Number: 5866-38M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2018
• Initial Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR