MAUDE Adverse Event Report: MEDTRONIC, INC. LEAD ADAPTOR KIT; ADAPTOR, LEAD, PACEMAKER

Model Number	5866-38M
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5071-35 lead; 5071-35 lead, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that both the left ventricular (lv) lead and adapter had high impedance measurements.It was noted that the lv tip electrode impedance had a high degree of variability with isometric left arm movements.It was also noted that noise was present on the electrogram (egm).It was noted that reprogramming was done, and both leads were turned off.No patient complications have been reported as a result of this event.

• Brand Name: LEAD 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: 8894039
• Report Number: 2182208-2019-01489
• Device Sequence Number: 1658622
• Product Code: DTD
• UDI-Device Identifier: 00681490136907
• UDI-Public: 00681490136907
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K911302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

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: 01/05/2018
• 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: 07/26/2019
• Initial Report FDA Received Date: 08/14/2019
• 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: 6725 PIN PLUG, 6935M62 LEAD, DTMA1D4 ICD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR