MAUDE Adverse Event Report: ABBOTT MEDICAL 8-CHANNEL ADAPTER, MDT, 10CM; SCS EXTENSION

Model Number	2311
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
Event or Problem Description
Related manufacturer reference numbers: 3006705815-2021-00896, 1627487-2021-01706.It was reported that the patient experienced pain at the ipg pocket site.Imaging revealed that the lead adapters had migrated under the generator.As a result, surgical intervention was undertaken on (b)(6) 2021 whereing the ipg and adapters were relocated resolving the issue.No products were implanted or explanted.

• Brand Name: 8-CHANNEL ADAPTER, MDT, 10CM
• Common Device Name: SCS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11391100
• Report Number: 1627487-2021-01705
• Device Sequence Number: 19658746
• Product Code: LGW
• UDI-Device Identifier: 05415067016119
• UDI-Public: 05415067016119
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2021

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: 11/14/2019
• Device Model Number: 2311
• Device Catalogue Number: 2311
• Device Lot Number: 6199318
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/28/2021
• 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: SCS EXTENSION; SCS IPG
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 88