|
Model Number 300-20 |
Device Problem
High impedance (1291)
|
Patient Problems
Seizures (2063); Therapeutic Response, Decreased (2271)
|
Event Date 06/02/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that device diagnostics resulted in high impedance (> 10,000 ohms).It was reported that the patient was reporting an increase in seizures.It was noted that the patient suffers from drop attacks which are believed to be due to the high impedance.It was reported that the drop attacks are normally controlled with vns.There was no recent trauma and the patient did not manipulate the device through the skin.The patient underwent generator and lead replacement.The explanted devices are expected to be returned for analysis, but have not been received to date.
|
|
Manufacturer Narrative
|
Device failure is suspected, but did not cause or contribute to a death or serious injury.
|
|
Event Description
|
Additional information was received that the generator and lead were returned to the manufacturer for evaluation.Product analysis was completed on the generator but has not been completed on the lead.In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.The battery, 2.945 volts, shows a non-ifi condition.The data in the diagaccumconsumed memory locations revealed that 14.910% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.
|
|
Manufacturer Narrative
|
Device failure is suspected, but did not cause or contribute to a death or serious injury.
|
|
Event Description
|
Additional information was received that product analysis was completed on the lead.Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing.The slice mark found on the (-) unmarked connector inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubing.What appeared to be white deposits were observed in various locations.Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, sulphur, chlorine and calcium.Refer to eds sheet for additional information.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to high impedance.Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
|
|
Search Alerts/Recalls
|
|
|