MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN STIMLOC SCREW; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	NEU_STIMLOC_ACC
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other applicable components are: product id: neu_ins_stimulator, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a distributor regarding a patient implanted with a neurostimulator.It was reported that the front end thread with the lock cap of the lead was broken.As a result a johnson screw was used to fix the passage, allowing the operation to be completed.The cause of the issue was unknown with the issue resolved at the time of the report.The patient is currently in good condition and receiving normal treatment.No further complications are anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a manufacturer representative (rep).It was clarified that the previously reported event was found intraoperatively, not out of the box.It was also clarified that the fracture was on the front side of the fixed electrode cap.The hcp used a johnson screw to open the channel, and then used the original manufacturer screw to complete the procedure.No further complications were reported/anticipated.

• Brand Name: UNKNOWN STIMLOC SCREW
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis,mn PR 55421 1200
• MDR Report Key: 7522025
• Report Number: 2649622-2018-08324
• Device Sequence Number: 13809386
• Product Code: MHY
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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: 07/03/2020
• Device Model Number: NEU_STIMLOC_ACC
• Device Catalogue Number: NEU_STIMLOC_ACC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1