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U.S. Department of Health and Human Services

Medsun Reports

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Type of Device:
vagus nerve stimulator
Device Brand Name:
VNS Therapy Aspire HC
Device Manufacturer's Name:
Cyberonics, Inc.
Date of this Report:
(mm/dd/yyyy)
09/05/2014
Describe the Event
or Problem:
Patient was taken to the operating room (OR) to have a battery change in the patient's Vagus Nerve Stimulator. Post-surgically there was concern that the device was not functioning correctly even though it had been previously checked in the OR. Indication is that the manufacturer has made changes to the device impedance thresholds that the surgical staff were not aware of. The Neurosurgeon is currently working with the manufacturer to identify a solution and will follow up with this particular patient's family (patient is a pediatric). There was concern post-operatively that the patient may need to return to the OR for an additional procedure. Manufacturer response: The Neurosurgeon contacted the Cyberonics representative directly and continued communicating with the company representative. The OR staff shared concern that they did not receive any prior communications regarding either software or hardware changes from the manufacturer. They say that the thresholds for impedance were changed by the manufacturer.
the device(s) may have
caused or contributed to:
Potential for patient harm
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