MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. STIMLOC; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number	3550S-01
Medical Device Problem Codes	Device Or Device Fragments Location Unknown (2590); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a health care provider (hcp) via a manufacturer's representative (rep) regarding a patient who was im planted with an implantable neuro stimulator (ins) for dystonia and movement disorders.It was reported that in the process of placing the screws to fixate the stimloc, the screws out of the lead kit either broke or would not bite the drill deep enough for complete seating in the skull, further stating that each time the stimloc had to be repositioned and this happened three times.1/2 screws purchased appropriately, the second screw did not and the tip may have broken, they backed out screws, repositioned stimloc and attempted using two new screws, and the same issue occurred.There were no environment/external or patient factors that would have led or contributed to the issue.It was reported that they tried using the new disposable stimloc driver with different screws but that did not remedy, however they replaced with additional single screw and it finally purchased.Both screws finally seated completely and the issue was resolved at the time of the report.One of the screws misfired, would not bite and was partially explanted.No patient symptoms were reported.No further patient complications were reported/ anticipated as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: STIMLOC
• Common Device Name: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• MDR Report Key: 7554031
• Report Number: 3012165443-2018-00004
• Device Sequence Number: 14343636
• Product Code: MRU
• UDI-Device Identifier: 00613994747204
• UDI-Public: 00613994747204
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: 3550S-01
• Device Catalogue Number: 3550S-01
• Device Lot Number: 082314217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 49