MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; PROBE, RADIOFREQUENCY LESION

Model Number 16-3-250

Device Problem Use of Device Problem (1670)

Patient Problem Paralysis (1997)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

Model number and description: stereotactic tc electrode model (1.6) (3) (250).

Event Description

It was reported that during a intracerebral thermocoagulation surgery to treat a patient with serious focal pharmacoresistant epilepsy, it was realized that a small part of the insolated sheath of the electrode was missing after surgery.It was suspected that part of the insulated sheath of the reusable stereotactic electrode had been removed perhaps during the sterilization process, so the lesion or burning had been bigger than expected.The procedure was unsuccessful and when the surgeon put electrode off the brain, he realized isolated sheath was missing, therefore he decided to stop the intervention.When the patient woke up post-operatively, his left foot was paralyzed.A few days later the patient recovered and was no longer experiencing paralysis.The patient has fully recovered.

Manufacturer Narrative

Box d4 model number and description: stereotactic tc electrode model 16-3-250.The clinical observation that this electrode was missing a portion of its outer insulation was confirmed through laboratory analysis.The wearing of the reusable electrode shafts outer coating is consistent with fatigue and overuse, most likely through the re-sterilization process.The most probable cause for this event is that the electrode had reached the end of its normal product life cycle and its re-sterilization capacity.Functional testing was conducted and all measurements were within normal range.The hospital reported that they were unaware of the number of times this reusable electrode had been re-sterilized before the wearing of the outer insulation-coating was observed.

Event Description

It was reported that during a intracerebral thermocoagulation surgery to treat a patient with serious focal pharmacoresistant epilepsy, it was realized that a small part of the insolated sheath of the electrode was missing after surgery.It was suspected that part of the insulated sheath of the reusable stereotactic electrode had been removed perhaps during the sterilization process, so the lesion or burning had been bigger than expected.The procedure was unsuccessful and when the surgeon put electrode off the brain, he realized isolated sheath was missing, therefore he decided to stop the intervention.When the patient woke up post-operatively, his left foot was paralyzed.A few days later the patient recovered and was no longer experiencing paralysis.The patient has fully recovered.

• Type of Device: PROBE, RADIOFREQUENCY LESION
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 10740861
• MDR Text Key: 213252309
• Report Number: 3006630150-2020-05184
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-3-250
• Device Lot Number: 061015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other