BOSTON SCIENTIFIC CORPORATION INVIVE; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
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Model Number V173 |
Device Problems
Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Syncope (1610); No Code Available (3191)
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Event Date 04/13/2020 |
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 this cardiac resynchronization therapy pacemaker (crt-p) had reached elective replacement indicator, and then a few days later the device was interrogated and found that the device had three memory errors that put it into safety core.The device was operating at vvi 72.5ppm, and the sensing was unipolar while in in safety core that was causing noise.A few days later the patient presented to the emergency room due to syncope.Subsequently, the patient underwent a revision procedure and this device was explanted and replaced.The device was planned to be returned for analysis.No additional adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had reached elective replacement indicator, and then a few days later the device was interrogated and found that the device had three memory errors that put it into safety core.The device was operating at vvi 72.5ppm, and the sensing was unipolar while in safety core that was causing noise.A few days later the patient presented to the emergency room due to syncope.Subsequently, the patient underwent a revision procedure and this device was explanted and replaced.The device was planned to be returned for analysis.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 both brady and tachy therapy remained available.Review of device memory identified an error that resulted in software resets performed in an attempt to correct an identified inconsistency.The battery was removed and detailed analysis was able to confirm the cell had a high internal resistance.The cause of the high resistance within the cell has not been determined, however likely resulted in the device error code and operation in safety mode.3191 code was used to denote surgical intervention.
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