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

Model Number	3708660
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2015
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
It was reported that in (b)(6) 2015 impedances were documented as case and 2, 3, 10 and 11 as high and there was no known reason for this.No further information was provided.

• 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: 9373776
• Report Number: 6000153-2019-00017
• Device Sequence Number: 535294
• Product Code: MHY
• UDI-Device Identifier: 00613994749116
• UDI-Public: 00613994749116
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

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: 09/28/2016
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR