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

Model Number 3387S-40

Device Problems Shipping Damage or Problem (1570); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8377815
• MDR Text Key: 137411986
• Report Number: 2649622-2019-03326
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169313491
• UDI-Public: 00643169313491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 02/28/2019
• Date Device Manufactured: 12/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 16 YR