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

Model Number 3387S-40

Device Problems Low impedance (2285); Malposition of Device (2616); Difficult to Open or Close (2921); Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician did a bilateral subthalamic nucleus (stn) lead placement and expressed that he had difficulty making the clip snap into the stimloc base.They did not visibly see any excess nylon molding.There were no factors that may have led or contributed to the issue.New stimlocs were offered but the physician declined and stated that he was able to force the caps into the stimloc base.Additional information was received from a healthcare provider (hcp), via the manufacturer¿s representative (rep) who reported during a stage 2 case the lead was checked using the twistlock cable and it was found there were low impedances on contact pairings 3/0 and 2/1 (ranging from 91-104).The surgeon removed the lead from the twistlock cable, inspected it, and wiped it down with a wet then dry sponge.The surgeon tested again with the same results.Impedances were tested on 0.7, 1.5, and 3.0 v with the same results with the lead appearing to be intact.The surgeon the connected the extension wire and neurostimulator,and the same results appeared during the impedance check.The surgeon decided to the leave the lead as is and considered replacing it in the future.It was noted that during the stage 1 case the surgeon pushed the lead down deeper due to it being found to be 3 mm superior to the intended plan an d it was suspected this could have potentially unknowingly caused the impedance issue.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12033432
• MDR Text Key: 261946533
• Report Number: 2649622-2021-12479
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169752290
• UDI-Public: 00643169752290
• 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
• Report Date: 06/21/2021

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: 03/09/2024
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA2E93K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 06/21/2021
• Date Device Manufactured: 05/12/2021
• 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: 64 YR