MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	3389S-40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other relevant device(s) are: product id: neu_stimloc_acc.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative via a healthcare professional (hcp) regarding patient who was implanted with a neurostimulator for parkinsons dual and movement disorders.It was reported the stimloc screw tip broke when screwing into the skull, and the hcp was unable to screw the stimloc into the skull.The hcp replaced with a new stimloc kit, and the issue was resolved at the time of the report.There were no environment/external/patient factors that may have led or contributed to the issue.The patient's status at the time of the report was alive-no injury.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id 924256 lot# 082215217a.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the rep and confirmed with the hcp.The lot number of the stim loc burr hole cover was provided.The product was to be returned.No further complications were reported.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7920647
• Report Number: 2649622-2018-15962
• Device Sequence Number: 1937177
• Product Code: MHY
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 06/01/2020
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1JSTQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR