MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. STIMLOC; COVER, BURR HOLE

Model Number 924256

Device Problems Break (1069); Unstable (1667)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported during the procedure one of the screws failed to fix the product correctly to the patient's head.When the hcp made a revision of the screw, he said that a part of the tip of the screw was broken.No environmental/external/patient factors were thought to have led or contributed to the issue.A backup stimoc screw was used to continue with the procedure.The issue was resolved at the time of the report.No surgical intervention was needed to prevent a permanent impairment and the event did not lead to or extend the patient hospitalization.The patient was alive without injury at the time of the report.No patient symptoms or complications were associated with this event.

• Brand Name: STIMLOC
• Type of Device: COVER, BURR HOLE
• Manufacturer (Section D): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer (Section G): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8278025
• MDR Text Key: 134196415
• Report Number: 3012165443-2019-00002
• Device Sequence Number: 1
• Product Code: GXR
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2021
• Device Model Number: 924256
• Device Catalogue Number: 924256
• Device Lot Number: 082209318A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 80