Model Number V173 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Code Available (3191); Insufficient Information (4580)
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Event Date 08/30/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that boston scientific technical services (ts) received a call about a red alert on the patient's device.Ts found the device had entered safety mode and the device had to be replaced.Programming options were discussed, and ts informed about the possibility of some sort of memory corruption.The device was explanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that brady therapy remained available.Review of device memory identified an error, which resulted in software resets that were performed in an attempt to correct the error.These resets then caused the device to enter safety mode.The battery was removed and detailed analysis was able to confirm the cell had a high internal impedance.The high internal impedance resulted in the software resets, reversion to safety mode operation and the reported clinical observations.
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Event Description
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It was reported that boston scientific technical services (ts) received a call about a red alert on the patient's device.Ts found the device had entered safety mode and the device had to be replaced.Programming options were discussed, and ts informed about the possibility of some sort of memory corruption.The device was explanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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