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

Model Number 3389-40

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

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

Event Date 05/01/2019

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 (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that when they were preparing the lead for implant, the surgeon placed the spacer and depth stop on the lead, connected it to the star drive tower and connected the tower to the fhc ruler.The lead was short of the edge by approximately 1-2 mm.The surgeon was not comfortable to implant.No environmental/external/patient factors were known to have led or contribute to the issue.They took apart everything and re-connected the spacer, the depth stop, the tower and the ruler and the same result was found.When they opened a new lead, connected spacer, depth stop, it went to the end of the ruler to show correct length.The surgeon was happy and the new lead was implanted without incidence.The issue was resolved at the time of the report.No patient symptoms or further complications were reported 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: 8605271
• MDR Text Key: 144872718
• Report Number: 2649622-2019-08106
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: 3389-40
• Device Catalogue Number: 3389-40
• Device Lot Number: VA1X7ZA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2019
• Date Device Manufactured: 01/08/2019
• 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: 54 YR