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

Model Number	3387S-40
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 healthcare provider (hcp) and a manufacturer representative (rep) regarding a patient with implanted leads for essential tremor and movement disorders.The rep reported that the patient was currently implanted with a lead only system.The rep reported that contact 0, being the contact most distal, was not fully insulated with the boot.No patient symptoms were reported.No further patient complications have been reported as a result of this event.[refer to manufacturer report #2649622-2018-02745 for details pertaining to the reportable related event.].
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Follow-up information was received from the hcp via the rep reporting that the patient did not experience any symptoms and the insulation question was the opinion of the hcp.The rep reported that the hcp claimed to have not put the boot on.The rep reported that it was unknown if the issue had resolved.No further patient complications have been reported as a result of 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: 7371641
• Report Number: 2649622-2018-02746
• Device Sequence Number: 37529
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2018

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: 11/22/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1FJ6X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1