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

Model Number	6373
Medical Device Problem Codes	Fracture (1260); Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); Movement Disorder (4412)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer report number 1627487-2024-07386 and 1627487-2024-07388.It was reported the device displayed the elective replacement indicator message and it is unknown if the device depleted prematurely.Prior to the surgery it was discovered the extensions had impedances.As a result, surgical intervention was undertaken the ipg, and extensions was explanted and replaced.Effective therapy was restored post operatively.
Additional Manufacturer Narrative
B3-date of event is estimated.
Additional Manufacturer Narrative
The report of high impedance was confirmed.Analysis of extension a found when testing the stimulation end segment for continuity that seven of the eight channels were ¿open¿.The fractures (opens) are consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 90CM, B
• Common Device Name: 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18866988
• Report Number: 1627487-2024-07387
• Device Sequence Number: 15497032
• Product Code: MHY
• UDI-Device Identifier: 05415067020864
• UDI-Public: 05415067020864
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2024
• 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): 04/18/2024

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: 02/28/2019
• Device Model Number: 6373
• Device Lot Number: 5872380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2017
• 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 (X2); DBS LEAD (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 71 KG