Model Number U128 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Purulent Discharge (1812); Unspecified Infection (1930); Complaint, Ill-Defined (2331)
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Event Date 04/02/2018 |
Event Type
Injury
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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 the patient with this cardiac resynchronization therapy pacemaker (crt-p) felt small shocks from the pocket.Boston scientific technical services (ts) then referred the patient to the physician.Additional information was received indicating that yellow pus was oozing from the wound site.The field representative mentioned for possible infection.As of this time, the device remains in service.No additional adverse patient effects were reported.
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Event Description
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Additional information indicated that the patient was in a motor vehicular accident (mva).Further, the patient was having chest pain, felt funny in the head and had fractured a breast implant.Boston scientific technical services (ts) then guided the patient in performing a patient initiated interrogation (pii).
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Search Alerts/Recalls
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