MAUDE Adverse Event Report: ABBOTT MEDICAL 8CH INFINITY DBS LEAD KIT, 30CM, 1.5, B

Model Number	6171
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	06/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event¿ is estimated.During processing of this complaint, attempts were made to obtain complete device and event information.
Event or Problem Description
Related manufacturer reference number: 1627487-2021-15321.It was reported that patient experienced tingling sensation in the arms, jaw, and neck.Diagnostic testing revealed high impedance on multiple contacts of the lead.Surgery may occur to address the issue.It is unknown which lead has high impedance so both leads are being reported.
Event or Problem Description
It was reported that the patient's leads were explanted on an unknown date.
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.

• Brand Name: 8CH INFINITY DBS LEAD KIT, 30CM, 1.5, 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: 12112737
• Report Number: 1627487-2021-15320
• Device Sequence Number: 4615367
• Product Code: MHY
• UDI-Device Identifier: 05415067030313
• UDI-Public: 05415067030313
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2021

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: 02/04/2022
• Device Model Number: 6171
• Device Catalogue Number: 6171
• Device Lot Number: 7375187
• 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: 06/29/2021
• Supplement Date Received by Manufacturer: 09/16/2021; 11/23/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 10/04/2021; 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2020
• 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 LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown