MAUDE Adverse Event Report: ABBOTT MEDICAL KIT SMALL CURVE DELIVERY SHEATH; DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF

Model Number	MN12150
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional components potentially involved in the event include: common device name: small curve delivery sheath kits, model: mn12150, udi: (b)(4) , serial: (b)(6) , batch: n/a.
Event or Problem Description
It was reported that of the patient's anchors (included in the small curve delivery sheath kit) migrated during the implant procedure on (b)(6) 2023.Investigation was unable to determine which of the anchor attributed to the event.
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: KIT SMALL CURVE DELIVERY SHEATH
• Common Device Name: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• 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: 17849605
• Report Number: 1627487-2023-04544
• Device Sequence Number: 14291024
• Product Code: PMP
• UDI-Device Identifier: 05415067025609
• UDI-Public: 05415067025609
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P150004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/20/2023

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: MN12150
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 10/01/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: DRG IPG (X1); DRG LEAD (X2); SMALL CURVE DELIVERY SHEATH KITS (X1)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 59 KG