MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B

Model Number	6170
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer report 1627487-2020-48515.Related manufacturer report 1627487-2021-01049.It was reported that high impedance issue was observed on the leads.One extension was explanted on (b)(6) 2021 procedure.High impedance issue was still observed, and lead damage was observed on one of the leads.Both leads were explanted, and new leads were implanted.It is unknown which lead had a damage issue therefore both leads are being reported.There were no complications during the procedure.Patient was stable.
Additional Manufacturer Narrative
The complaint for high impedance was not confirmed.Two leads were returned, they were designated lead a and lead b.Lead a was returned complete.Microscopic inspection revealed, instrumentation damage to the lead body 12.9cm distal to the stimulation end.The lead was functionally tested and passed all testing.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B
• Common Device Name: DBS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11299075
• Report Number: 1627487-2021-01048
• Device Sequence Number: 4830887
• Product Code: MHY
• UDI-Device Identifier: 05415067020635
• UDI-Public: 05415067020635
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2021

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: 01/31/2018
• Device Model Number: 6170
• Device Catalogue Number: 6170
• Device Lot Number: 5359595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/07/2021
• 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: DBS EXTENSION; DBS LEAD; DBS EXTENSION; DBS LEAD
• Outcome Attributed to Adverse Event: Other