MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, 30CM; SCS EXTENSION

Model Number	3383
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/19/2021
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 initial reporter information.Further information was requested but not received.
Event or Problem Description
It was reported the patient lost effective therapy.Diagnostics indicated high impedances.In turn, the extension was explanted.Therapy was restored postoperatively.
Additional Manufacturer Narrative
The reported event for high impedance was confirmed.As returned, microscopic inspection of the returned extension revealed multiple broken wires inside the header.The root cause is consistent with an overstress condition or sudden event that the extension may have been subjected to while still in vivo.

• Brand Name: EXTENSION, 30CM
• Common Device Name: SCS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11931134
• Report Number: 1627487-2021-14606
• Device Sequence Number: 11860869
• Product Code: LGW
• UDI-Device Identifier: 05415067017918
• UDI-Public: 05415067017918
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 3383
• Device Catalogue Number: 3383
• Device Lot Number: 4354468
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other