MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B

Model Number	6170
Medical Device Problem Codes	Fracture (1260); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer reference number: 1627487-2022-06924.It was reported the patient¿s lead and extension were both replaced due to high impedance and a possible fracture.It is unknown if the lead or extension was fractured at this time.
Additional Manufacturer Narrative
A patient experiencing high impedance was reported to abbott.The patient¿s lead was explanted and replaced.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 event could not be conclusively determined.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 30CM, 0.5, B
• Common Device Name: DBS LEAD
• 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: 16001673
• Report Number: 1627487-2022-06925
• Device Sequence Number: 6570645
• Product Code: MHY
• UDI-Device Identifier: 05415067020635
• UDI-Public: 05415067020635
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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): 02/22/2023

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: 01/15/2021
• Device Model Number: 6170
• Device Catalogue Number: 6170
• Device Lot Number: 6801032
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 12/18/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2019
• 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: Female