Model Number 7741 |
Device Problems
Capturing Problem (2891); Device Contamination With Biological Material (2908); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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Boston scientific received information that during the implant of this right ventricular (rv) lead the physician was attempting manipulate the helix in order to fixate the lead into the heart, but the helix got entangled with myocardium from the tip of the lead and it was not possible to manipulate.The rv lead had dislodged.It was not possible to retract the helix by rotating it clockwise after more than sixty turns.The pacing thresholds and sensing amplitudes were not good thus the lead was extracted.It was noted that the helix of the rv lead was stretched and not stable.A new lead was used.This lead will not be returned due to the patient infectious disease.
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Event Description
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No adverse patient effects were reported.
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Search Alerts/Recalls
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