Model Number 87029 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Event Description
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During an ablation procedure to treat atrioventricular reciprocating tachycardia a rhythmia patch cable was selected for use.It was reported that the backpatch cable was not registering on the rhythmia.Mapping system and error message - 1318 the back patch is poorly connected was observed.The system was rebooted several times, however, the error message was not resolved.The procedure was abandoned when the physician realized the proximity of the accessory pathway to the patient's own conduction system.The patient had mild sedation and was not under general anesthesia at time of procedure cancellation.
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Manufacturer Narrative
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Facility phone number was added to e1.With all the available information, boston scientific concludes the reported observation of unable to visualize backpatches was confirmed through investigational analysis.The rhythmia backpatch cable was returned to boston scientific for analysis.Visual inspection did not find any anomalies.The cable did not pass functional testing as it was unable to visualize the backpatches on a rhythmia system during testing.
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Event Description
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During an ablation procedure to treat atrioventricular reciprocating tachycardia a rhythmia patch cable was selected for use.It was reported that the backpatch cable was not registering on the rhythmia.Mapping system and error message - 1318 the back patch is poorly connected was observed.The system was rebooted several times, however, the error message was not resolved.The procedure was abandoned when the physician realized the proximity of the accessory pathway to the patient's own conduction system.The patient had mild sedation and was not under general anesthesia at time of procedure cancellation.
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Search Alerts/Recalls
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