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

Model Number	6170
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date is estimated.
Event or Problem Description
It was reported that the patient was experiencing high impedances, and then it was later discovered that the lead was fractured.Surgical intervention was undertaken and the lead was explanted and replaced.
Additional Manufacturer Narrative
Conclusion: the report event of impedance issue was not confirmed.As received, visual inspection and resistance testing showed the returned lead passed the functional test.The cause of the reported event remains unknown.

• 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: 15591518
• Report Number: 1627487-2022-05605
• Device Sequence Number: 2327730
• Product Code: MHY
• UDI-Device Identifier: 05415067030306
• UDI-Public: 05415067030306
• 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: 2021
• 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): 12/21/2022

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: 10/30/2021
• Device Model Number: 6170
• Device Catalogue Number: 6170
• Device Lot Number: 7252650
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female