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

Model Number 5866-38M

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Impedance Problem (2950)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2019

Event Type  Injury  

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 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
• Type of Device: ADAPTOR, LEAD, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8894039
• MDR Text Key: 154303919
• Report Number: 2182208-2019-01489
• Device Sequence Number: 1
• Product Code: DTD
• UDI-Device Identifier: 00681490136907
• UDI-Public: 00681490136907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2019
• Date Device Manufactured: 01/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6725 PIN PLUG, 6935M62 LEAD, DTMA1D4 ICD
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR