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

Model Number	3387S-40
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2019
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 manufacture representative (rep) regarding a patient who was implanted with an implantable neuro stimulator (ins) it was reported that the first three leads were fine, it was the fourth that was the issue.Rep stated that they implanted the lead, tested it, and 3 and 1 contact would not read, saying there was a fault between 3 and 1.Took twist lock off and put another twist lock on.Tested the lead and the issue was still present.Used alligator clips to test the lead, issue still present.Explanted lead and put in a new one.Tested with 2nd twist lock.3 and 0 did not work shifted twist lock cable(took it off, unplugged from external neurostimulator stimulator -ens, plugged it back into to ens, and the fault resolved itself.) rep stated these are both out of box failures.The rep noted this is the second time this has happened and confirmed it was documented by a different a rep.No symptoms were reported.No further patient complications were reported/ anticipated 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: 8377815
• Report Number: 2649622-2019-03326
• Device Sequence Number: 18939987
• Product Code: MHY
• UDI-Device Identifier: 00643169313491
• UDI-Public: 00643169313491
• 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
• Report Date (Section B): 02/28/2019

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: 09/11/2021
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1WPZ8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR