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

Model Number 3389S-40

Device Problems Break (1069); Device Damaged by Another Device (2915)

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 healthcare provider via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for essential tremor and deep brain stimulation (dbs) therapy indications.It was reported that on contact zero on the dbs neuro lead appeared to have been damaged by the set screw of the lead end cap.Damage to contact zero was discovered after the lead end cap was removed from the distal end of the lead prior to connecting the lead to the dbs extension wire during this phase 2 procedure.There were no apparent environmental or external factors that lead to this.Diagnostics/troubleshooting included the physician attempting to salvage the crushed and deformed contact zero to the best of his ability and proceed with connecting the lead to the extension wire.Interventions/actions included the surgeon wrapping the exposed wire for contact zero around the lead in the position where the contact zero resides.After the system was fully assembled with all set screws tightened, an impedance check was performed.The results of the check showed that all impedances were within normal ranges.The doctor acknowledged these results.The impedance check was repeated as surgical closure was initiated with no change observed in the results.The results of the impedance check were saved to the patient¿s neurostimulator.The issue is reported to be resolved.The doctor stated that during the procedure he felt that the damage to contact zero on the lead was the result of the set screw in the lead end cap crushing the contact.No surgical intervention occurred or was planned.No symptoms were reported.No further complications were reported or anticipated with this event.

Manufacturer Narrative

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

• 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: 8372067
• MDR Text Key: 137247862
• Report Number: 2649622-2019-03172
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1VCX8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2019
• Date Device Manufactured: 10/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1190-2013
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 78