MAUDE Adverse Event Report: ABBOTT MEDICAL SLIMTIP¿; DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF

Model Number DRG

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2022

Event Type  malfunction  

Event Description

Surgeon noticed the tip of the slimtip sheath had broken off inside the patient.With the c-arm and making a small incision surgeon was unable to retrieve the piece of sheath.Surgeon made a call to another surgeon for assistance.Upon completion of the phone call, it was determined to leave the piece of sheath in place at this time.The slim tip sheath came from the abbott slimtip drg package.Ref number: (b)(4).Sn # (b)(4).

• Brand Name: SLIMTIP¿
• Type of Device: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston road; plano TX 75024
• MDR Report Key: 16426888
• MDR Text Key: 310066002
• Report Number: 16426888
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DRG
• Device Catalogue Number: MN10450-50A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Sex: Male