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

Model Number	3383
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that the patient was unable to enter mri mode due to high impedances.As a result, the patient underwent surgical intervention on (b)(6) 2024 to explant both extensions (related manufacturer reference number: 1627487-2024-10087).
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.
Event or Problem Description
Additional information was obtained, revealing that the patient had experienced ineffective therapy, prior to surgery.

• Brand Name: EXTENSION, 30CM
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19980646
• Report Number: 1627487-2024-10088
• Device Sequence Number: 20891688
• Product Code: LGW
• UDI-Device Identifier: 05415067017918
• UDI-Public: 05415067017918
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• 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): 09/18/2024

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 Model Number: 3383
• Device Catalogue Number: 3383
• Device Lot Number: 103010400
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 66 KG