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

Model Number	6373
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).
Event or Problem Description
It was reported that during the patient's unrelated elective ipg replacement on (b)(6) 2024, the physician had trouble unscrewing the lead extensions from the ipg header, and had damaged them.As a result, lead extensions were explanted and replaced.
Additional Manufacturer Narrative
The reported extension removal issue from the ipg was not confirmed.As received, microscopic inspection revealed both the extension "a" and "b" had terminal contacts damaged.No further testing could be done.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 90CM, B
• Common Device Name: DBS LEAD 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: 19671175
• Report Number: 1627487-2024-09661
• Device Sequence Number: 6851796
• Product Code: MHY
• UDI-Device Identifier: 05415067020864
• UDI-Public: (01)05415067020864(10)6168927(17)190612
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2019
• Device Model Number: 6373
• Device Catalogue Number: 6373
• Device Lot Number: 6168927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2017
• 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 IPG.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown