MAUDE Adverse Event Report: ABBOTT MEDICAL KIT LEAD EXTENSION, 50CM; DRG EXTENSION

Model Number	MN20550-50
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer report number 1627487-2022-01412.It was reported that the patient was not receiving effective therapy from their system.It was found that the lead had low impedance.In turn, surgical intervention was undertaken on (b)(6) 2022 wherein the setscrew of the extension was stuck, then broke when opening the port of the extension.The hex wrench was used to open the port.The lead was removed from the extension and measured with a trial cable; all impedances were between 400-600 ohm.Extension was to be replaced, but while clearing the extension, it was difficult to differentiate the lead from the extension and the curled up lead and extension were mixed.During this, the lead was then explanted and the extension remains implanted.
Additional Manufacturer Narrative
The report event of low impedance cannot be fully analyzed and confirmed due to the lead extension was not returned.As received, the returned setscrew was microscopic inspection no anomalies/damage was found.The cause of the reported event remains unknown.
Event or Problem Description
Additional information revealed that the patient underwent surgical intervention on 30mar2022 wherein the extension was cut and explanted and a new lead was implanted.Postoperatively, the patient has effective therapy.

• Brand Name: KIT LEAD EXTENSION, 50CM
• Common Device Name: DRG 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: 13763152
• Report Number: 1627487-2022-01411
• Device Sequence Number: 2519334
• Product Code: PMP
• UDI-Device Identifier: 05415067025562
• UDI-Public: 05415067025562
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 04/12/2022

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: 01/31/2017
• Device Model Number: MN20550-50
• Device Catalogue Number: MN10550-50
• Device Lot Number: AB2032
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 48 YR
• Patient Sex: Male