Model Number T177 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438); Ambient Noise Problem (2877)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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Additional information regarding the expected date of the procedure has been requested.No additional information is available at this time.If additional information becomes available this report will be updated.
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Event Description
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Boston scientific received information that this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead exhibited noise and oversensing on the rv lead resulting in inappropriate ventricular tachycardia (vt) episodes.It was reported that the device is at eri and the lead plans to be replaced at the upcoming device replacement procedure.No adverse patient effects were reported.
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Event Description
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Additional information received from the local field representative indicated that the rv lead was successfully explanted during the device replacement procedure.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) and the right ventricular (rv) lead exhibited noise and oversensing resulting in inappropriately recorded ventricular tachycardia episodes.This icd reached elective replacement indicator status and the rv lead was planned to be replaced at this upcoming procedure.Eventually, both of these products were replaced.This icd is not expected to be returned for analysis and no additional adverse patient effects were reported.
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Manufacturer Narrative
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This follow-up 001 report was not submitted previously.As per request by the fda on january 10, 2024, follow-up 001 has been resubmitted in an effort to release follow-up 002 from hold status.
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Search Alerts/Recalls
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