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

Model Number	3389S-40
Medical Device Problem Codes	Bent (1059); Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event occurred in (b)(6).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 with an implantable neurostimulator (ins).It was reported that the lead electrode was found to have been bent in the operation.The new electrode was replaced to complete the operation.The reason for failure was unknown, however the issue was resolved.Troubleshooting was unknown.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 clarified that the product damage occurred during surgery.No further complications were reported/anticipated.

• 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: 7336742
• Report Number: 2649622-2018-02711
• Device Sequence Number: 681859
• Product Code: MHY
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: CH
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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: 04/18/2020
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1HK4X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR