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

Model Number	3389S-40
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient with an implanted neurostimulator (ins).It was reported that the patient had high impedance after lead implantation.The impedances were checked twice at 3.0 v and both times they were high on contact 2.The hcp switched the lead out and the impedances were normal.No patient symptoms or further complications were reported as a result of this event.
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 the rep.It was reported they didn't want to test the impedances because they get high.The high on electrode two changed position of the lead and the impedances went back down.No further complications were reported as a result of this event.
Additional Manufacturer Narrative
Additional review indicates that information from manufacturer¿s report #3007566237-2017-04998 was already reported in this report ( #2649622-2017-10168).Any additional information regarding that event will be submitted as a supplemental submission to this report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider via a manufacturing representative regarding a patient who was implanted with a neurostimulator.It was reported the last time the healthcare provider had high impedances when placing a lead, they replaced everything and the impedance remained the same.No symptoms 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): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6857774
• Report Number: 2649622-2017-10168
• Device Sequence Number: 10987742
• Product Code: MHY
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2017

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: 04/10/2020
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1H8BA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 11/30/2017; 12/07/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 12/04/2017; 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 55