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

Model Number 3387S-40

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/10/2019

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 manufacturing representative (rep), regarding a patient with an implantable neurostimulator (ins) for the treatment of parkinson's disease.It was reported that during the stage 2 procedure when the brain lead end cap was exposed through the scalp incision, it was noticed that approximately 1cm of the lead insulation was not covering the wiring.This was at the very distal end of the lead just prior to the contacts.The surgeon believed that the insulation disconnected upon extraction on the lead from the scalp incision.The hcp reported that they did not pull on the lead with any degree of force.They commented that the system "is very fragile." it was unclear whether the hcp was intending to indicate this particular lead or as a general statement regarding the device.No environmental/external or patient factors were stated to be known that may have contributed to the event.It was stated the hcp was able to "manipulate the insulation back over the wiring." the wiring was stated to not appear to be damaged.The boot was applied as per the usual process and the lead was connected to the extension.Impedances were performed and were all within normal limits.It was stated the issue was resolved at the time of the report.No patient symptoms were reported.No further complications were reported or anticipated with 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: 9192874
• MDR Text Key: 162841124
• Report Number: 2649622-2019-18889
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2020
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1N87D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2019
• Date Device Manufactured: 01/12/2018
• 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: 65 YR
• Patient Weight: 77