MAUDE Adverse Event Report: NEUROPACE RNS NEUROSTIMULATOR KIT; IMPLANTED BRAIN STIMULATOR FOR EPILEPSY

Model Number RNS-320-K

Device Problem Communication or Transmission Problem (2896)

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

Event Date 07/06/2018

Event Type  malfunction  

Event Description

Patient with medically intractable complex partial epilepsy underwent stereotactic placement of bilateral mesial temporal responsive neurostimulation (rns) depth electrodes and placement of right parietal neuropace rns neurostimulator.The neurostimulator was positioned within the ferrule and secured by tightening the set screw with a torque limiting screwdriver.The electrodes were positioned and then connected to the neurostimulator.After tightening the screws, the team attempted an impedance check.They were unable to obtain an appropriate signal between the telemetry head as the neurostimulator.Multiple attempts were made and they changed the telemetry head and rehabilitated the programming computer.The neuropace representative called technical support and attempted several other maneuvers, all of which were unsuccessful in establishing communication between the programming system and the neurostimulator.The surgeon elected to remove the existing neurostimulator and replace it.A new neurostimulator was opened and brought onto the operative field.The connector assembly was transferred from the old stimulator to the new one and secured by tightening the set screw with a torque limiting screwdriver.An impedance check was performed on the new neurostimulator revealing good impedances and recordings were obtained from both mesial temporal electrodes.All contacts were working properly.The non-working neurostimulator was removed from the operative field and returned to the neuropace representative.

• Brand Name: RNS NEUROSTIMULATOR KIT
• Type of Device: IMPLANTED BRAIN STIMULATOR FOR EPILEPSY
• Manufacturer (Section D): NEUROPACE; 455 n. bernardo avenue; mountain view CA 94043
• MDR Report Key: 7725928
• MDR Text Key: 115219775
• Report Number: 7725928
• Device Sequence Number: 1
• Product Code: PFN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RNS-320-K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8760 DA
• Patient Weight: 70