MAUDE Adverse Event Report: ABBOTT MEDICAL QUATTRODE LEAD, 3/6MM, 60 CM; PERCUTANEOUS LEAD

Model Number	3156
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient lost therapy.Troubleshooting revealed high impedances on the entire lead.As a result, surgical intervention was undertaken on (b)(6) 2021 wherein the lead was explanted and replaced.Issue resolved.
Additional Manufacturer Narrative
The report event of high impedances was confirmed.Microscopic inspection of the returned lead identified a kink on the lead body where all internal wires were broken.The cause is consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.

• Brand Name: QUATTRODE LEAD, 3/6MM, 60 CM
• Common Device Name: PERCUTANEOUS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11479012
• Report Number: 1627487-2021-02008
• Device Sequence Number: 3412680
• Product Code: LGW
• UDI-Device Identifier: 05414734401623
• UDI-Public: 05414734401623
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

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: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: 3156
• Device Catalogue Number: 3156
• Device Lot Number: 6776404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 04/07/2021
• 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: Other