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

Model Number	3387S-40
Medical Device Problem Codes	High impedance (1291); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding a stimloc lead.It was reported there was a high impedance for contact 0 on the lead when using an alligator clip to check during an impedance reading.The contacts 1, 2, and 3 were all within normal range and could increase in amplitude without error.The impedance on contact 0 was reported to be 3043 ohms.When the interoperative testing with an ens was performed contact 0 wouldn't exceed 2.5 but the rest of the contacts performed without a problem.The lead was replaced with another lead from the same lot and all the impedances were reported to be within normal range and no further problems occurred when increasing the amplitude during testing.The issue was resolved at the time of the report.No further complications were reported as a result of this event.
Event or Problem Description
Additional information was received.The high impedance was not determined and was an unknown cause.Patient information was updated.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.(b)(4) replaces previous codes of type.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis of the lead model 3387s.No anomalies were identified.If information is provided in the future, a supplemental report will be issued.

• 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: 6604572
• Report Number: 2649622-2017-04954
• Device Sequence Number: 1170660
• Product Code: MHY
• UDI-Device Identifier: 00643169516540
• UDI-Public: 00643169516540
• Combination Product (Y/N): N
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/11/2017

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: 10/20/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1FGWD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: Not provided; 07/26/2017; 07/26/2017; 08/18/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 06/06/2017; 07/27/2017; 09/07/2017; 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 68