MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 30CM; SCS EXTENSION

Model Number	3343
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.During processing of this incident, attempts were made to obtain complete event information.
Event or Problem Description
Related manufacturer reference number: 1627487-2021-16694.Related manufacturer reference number: 1627487-2021-16695.Related manufacturer reference number: 1627487-2021-16698.It was reported patient had loss of therapy due to the ineffective coverage of dual occipital and dual supra orbital system.Images indicated that the dual extension were kinked and fractured.As a result, surgical intervention took place wherein the ipg and one extension was explanted and replaced with new ones.Post operatively effective stimulation was restored.It is unknown which extensions addressed the issue and therefore all extensions are being reported.
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: EXTENSION, DUAL 4 CHANNEL 30CM
• Common Device Name: SCS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12393095
• Report Number: 1627487-2021-16696
• Device Sequence Number: 17059297
• Product Code: LGW
• UDI-Device Identifier: 05414734402293
• UDI-Public: 05414734402293
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 08/28/2015
• Device Model Number: 3343
• Device Catalogue Number: 3343
• Device Lot Number: 4214713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL 3343; MODEL 3383; MODEL 3789; MODEL 3343; MODEL 3383; MODEL 3789
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 91