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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: event date is estimated.
Event or Problem Description
It was reported that the patient's extension was showing high impedances.Surgical intervention was undertaken and the extension was explanted and replaced.
Additional Manufacturer Narrative
The reported impedance issues was confirmed.As received, microscopic inspection of lead extension revealed all wires were found fractured.The damage is consistent with the overstress conditions or sudden event the lead extension was subjected that would cause the impedance issue as reported while 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
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16553946
• Report Number: 1627487-2023-01159
• Device Sequence Number: 20105867
• Product Code: MHY
• UDI-Device Identifier: 05415067020864
• UDI-Public: 05415067020864
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2019
• Device Model Number: 6373
• Device Catalogue Number: 6373
• Device Lot Number: 6234826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DBS BURR HOLE CAP.; DBS IPG.; DBS LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 77 KG