MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 90CM, B; DBS EXTENSION

Model Number	6373
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Date of event is estimated.
Event or Problem Description
It was reported that the patient's extension was displaying high impedances.As a result, the extension was replaced.
Additional Manufacturer Narrative
The report of high impedance was confirmed.Analysis of the returned lead extension found it was damaged prior to being returned.The terminal end of the extension was missing; this segment was found to be stuck in the returned ipg (see per-2020-0234495-01) header port 9-16.The segment was removed from the port however, a contact remained stuck in the header block and was not able to be extracted.Microscopic inspection of the returned extension found a kink on the outer tubing approximately 19.0cm from the stimulation (header) end of the lead where all internal wires were broken.These fractures are consistent with an overstress condition or sudden event the extension was subjected to while still in vivo.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 90CM, B
• Common Device Name: DBS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11111077
• Report Number: 1627487-2021-00024
• Device Sequence Number: 3950635
• Product Code: MHY
• UDI-Device Identifier: 05415067020864
• UDI-Public: 05415067020864
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 03/17/2021

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: 05/24/2021
• Device Model Number: 6373
• Device Catalogue Number: 6373
• Device Lot Number: 6994872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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