MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 10CM; SCS EXTENSION

Model Number	3341
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer reference number: 1627487-2022-02171.It was reported the patient was experiencing uncomfortable stimulation when pressing on the ipg.Diagnostic testing showed high impedance on one contact.As a result, surgical intervention took place wherein the physician replaced the extensions to address the issue.
Additional Manufacturer Narrative
The reported event for inadequate shock/stimulation cannot be confirmed through products testing alone.Returned lead extension passed continuity and output resistance measurement.No root cause was identified for the loss of stimulation.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• Common Device Name: SCS 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 14269348
• Report Number: 1627487-2022-02172
• Device Sequence Number: 4354593
• Product Code: LGW
• UDI-Device Identifier: 05414734402279
• UDI-Public: 05414734402279
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 01/30/2022
• Device Model Number: 3341
• Device Catalogue Number: 3341
• Device Lot Number: 7363590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• 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: SCS IPG; SCS LEAD (X4)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 77 KG