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

Model Number 3389S-40

Device Problems Unstable (1667); Human-Device Interface Problem (2949)

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

Event Date 03/11/2019

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 healthcare provider via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins).It was reported that after proper lead testing was complete, the surgeon inserted stimloc secure clip into base ring via disk arm, then rotated it so the cam arm could be inserted into the moth and rotate to lock it around the lead body.They confirmed that it was locked and removed stylet.While drawing the lead down the cannula, they noticed that the secure clip was not holding the lead even though it was still in locked position.They had enough excess lead to route into base exit slot and secured with final cap.Diagnostics/troubleshooting included them using the cam arm to ensure secure clip was engaged, but lead still was not being held in place by it.Unknown if the issue is resolved.No symptoms reported.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider reporting that the cause of the secure clip not holding the lead was not determined.Pre-testing prior to lead placement was fine.The issue is not yet resolved.They relied on cap to hold the lead in place since the secure clip was dislodging.The lead was further manipulated intr-op.

• 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: 8424818
• MDR Text Key: 138932026
• Report Number: 2649622-2019-04435
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169752276
• UDI-Public: 00643169752276
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1XVAQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• Date Device Manufactured: 02/01/2019
• 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: 65 YR