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	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See previously reported events under rr # 6000153-2019-00015, and 6000153-2019-00017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was stated the patient was having routine battery replacement for eri status.A manufacturing representative (rep) attended the case.Prior to the ins change, it was noted contacts case and 3 and case and 11 were high.During the ins change the impedances showed high values on case and 3 case and 1 and all bipolar configurations.The right side showed high impedances on all contacts.The hcp disconnected and reconnected both channels, at which time the left side continued to show high values on case and 3 case and 1 and all bipolar configurations.The right side went back to baseline which was on case and 11 high.The hcp was with the patient post-op as they were about to be discharged and in checking impedances again indicated summary tab showed contacts 0, 2, and 3 with xs and "avoid" and contact 1 was red and "not used." in electrode tab, c-3 and c-1 show "high" but c-2 and c-0 show 757 ohm; all bipolar pairs show "high" with red x's.The hcp stated the patient was currently programmed on c-0 and it was inquired if they had to turn the ins off due to these impedance readings.It was reviewed that if the patient was currently programming on c-0, it appeared that the pair was ok to use if impedance was within normal range.It was also reviewed that even if the patient were programmed on any of the "high" pairs, it wouldn't do harm to the ins but that high impedances conserve battery life.It would be unlikely that the patient would receive therapy.It was stated they may look at adding contact 2 into programming when the patient returns to the office.Upon reviewing history for original base line high impedance, it was indicated that on (b)(6) 2015 impedances were abnormal and that in (b)(6) 2015, impedances were documented as case and 2, 3, 10, and 11 as high with no known reason for this.(b)(6) 2017 impedances were documented as case and 3 as high with no known reason why.
Additional Manufacturer Narrative
Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received that the patient was still programmed using case and 0, since that combination did not have an impedance issue and the patient was stated to be receiving therapy.No further information was available.

• 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: 9373817
• Report Number: 6000153-2019-00019
• Device Sequence Number: 3091188
• 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,Followup
• Report Date (Section B): 12/16/2019

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
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 64