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

Model Number	3387S-40
Medical Device Problem Codes	High impedance (1291); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
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 (rep) regarding a patient who was implanted with a lead.It was reported that the lead had slightly high impedances on contact zero out of box.Unknown if any environmental/external/patient factors may have led to the issue.The patient had a new initial implant at the right stn.Surgeon placed lead.Impedance was taken with alligator clip and contact 0 came back with 4700 ohms.Surgeon re-connected alligator clip and impedance was taken again.Still in the 4700 range.Stimulated on contact 0 for 1 minuted in the operating room then increased to 3v retested impedance at 3v and took impedance and it was at 4300 ohms.Tested contact 1 impedance and it was at 1500 ohms and tested contact 3 and it was at 1700 ohms.They replaced the electrode with a new electrode which impedance came back within normal range under 2000 ohms for each contact.At 0.7v.This was the final electrode implanted.The issue is reported to be resolved.The rep was unable to determine if the lead would be returned.No symptoms are reported.No further complications were reported or anticipated with 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 manufacturing representative indicating that the cause of the high impedances was not determined.The status of the affected lead is unknown.This information has been confirmed by the healthcare provider.

• 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: 7562722
• Report Number: 2649622-2018-09196
• Device Sequence Number: 2194141
• Product Code: MHY
• UDI-Device Identifier: 00643169516540
• UDI-Public: 00643169516540
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: 10/25/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1FUQ8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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