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

Model Number 924256

Device Problem Unstable (1667)

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

Event Date 01/09/2019

Event Type  Injury  

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) regarding a patient who was implanted with a neurostimulator (ins) for movement disorders.It was reported that the inner clip of the stimloc was not holding the dbs lead.After clipping the lead it pulled back a couple of cm and had to be put back in place.O arm scan at the end confirmed that the lead was relocated to the correct depth.The clip was repositioned but was still not holding the lead as well as usual.The stimloc cal was then put in to further secure the lead.The issue was resolved.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare provider (hcp), reported there was no reason for the clip not holding.The clip was still implanted and would not be returned.No further patient symptoms or complications were anticipated.

• 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: 8237428
• MDR Text Key: 132941172
• Report Number: 3012165443-2019-00001
• Device Sequence Number: 1
• Product Code: GXR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2021
• Device Model Number: 924256
• Device Catalogue Number: 924256
• Device Lot Number: 082225418A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 60