MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	37085-60
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
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 manufacturing representative regarding a patient who was implanted with a neurostimulator (ins) for parkinsonian tremor.It was reported that the extension wire was damaged by a surgical tool.Diagnostics/troubleshooting involved were electrical integrity tests performed intra-operatively and post-operatively.No interventions/actions were taken to resolve the issue.Therapy impedances indicated normal circuits.Patient caregiver informed that condition of extension wire could degrade and that, in that case, a replacement could be performed.The issue is not resolved.No surgical interventions has occurred or is planned.No patient symptoms were reported.No further complications were reported or anticipated with this event.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 7598729
• Report Number: 6000153-2018-00013
• Device Sequence Number: 178492
• Product Code: MHY
• UDI-Device Identifier: 00613994353528
• UDI-Public: 00613994353528
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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: 05/06/2014
• Device Model Number: 37085-60
• Device Catalogue Number: 37085-60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 75