MAUDE Adverse Event Report: ABBOTT MEDICAL DBS SINGLE EXTENSION; DBS EXTENSION

Model Number	6346
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Movement Disorder (4412); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.During processing of this incident, attempts were made to obtain complete event information.Further information was requested but not received.
Event or Problem Description
It was reported that patient underwent a surgery wherein the extensions were explanted and replaced.The reason for the surgery is unknown.Reportedly, effective therapy was restored post op.The explanted extensions were discarded.
Event or Problem Description
Additional information received indicates that impedance check revealed high impedances.During the procedure it was identified that the extension had fractured.
Event or Problem Description
Additional information received indicates that the patient¿s therapy was turning off on its own when trying to increase stimulation strength.Impedance check revealed high impedances.During the surgery, intra-op testing just on the leads revealed normal impedance, however, when tested with the extensions connected, there were high impedance.Extensions fracture was identified.Hence, the extensions were replaced to address the issue.
Additional Manufacturer Narrative
Corrected data: h6 health effect - clinical code and medical device problem code.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.

• Brand Name: DBS SINGLE EXTENSION
• 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: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 21370012
• Report Number: 1627487-2025-00669
• Device Sequence Number: 8563976
• Product Code: MHY
• UDI-Device Identifier: 05414734403252
• UDI-Public: (01)05414734403252(10)8042857(17)230728
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 07/28/2025

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: 07/28/2023
• Device Model Number: 6346
• Device Catalogue Number: 6346
• Device Lot Number: 8042857
• Was Device Available for Evaluation?: No
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 02/14/2025; 03/06/2025; 07/26/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/05/2025; 03/20/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown