Model Number V173 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.
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Event Description
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It was reported that device interrogation identified a message that this device was in safety mode.A boston scientific technical services consultant recommended immediate device replacement.The device was explanted and returned for testing.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.A review of the device memory identified a system fault.The device case was removed to facilitate inspection of the internal components and further testing.Detailed analysis of the battery identified an internal short, which was caused by a tear in the cathode insulating tube.The short resulted in the fault identified in the laboratory setting and in the clinically-observed reversion to safety mode operation.
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Event Description
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This supplemental report is being filed due to the completed evaluation of this product.
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Search Alerts/Recalls
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