Model Number 1297 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885); Communication or Transmission Problem (2896)
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Patient Problems
Bruise/Contusion (1754); Fall (1848)
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Event Date 11/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
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Event Description
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Boston scientific received information that the patient implanted with this pacemaker presented to the emergency room after a fall.It was unknown if the device was hit during the fall, however, the patient had a bruise about 1-2 inches from the device implant location.The patient was noted to be in atrial fibrillation (af) with a rate of 68 beats per minute (bpm).The pacemaker was unable to be interrogated with a programmer and a magnet response was unable to be obtained.It was noted that during an in clinic follow up approximately one month ago, the device showed a battery status of less than 6 months remaining.Boston scientific technical services (ts) recommended device replacement.An invasive procedure was performed.The device was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received that the product is in possession of the hospital.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
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Manufacturer Narrative
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This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.High powered visual examination identified no anomalies.No dents or other external damage were noted.It was confirmed the header was firmly affixed to the device case.Interrogation of the device was not possible.Additionally, a memory download could not be performed and there was no pacing output.The device case was removed to facilitate inspection and testing of the internal components.The battery voltage was found to be lower than expected.The device¿s battery was removed and replaced with an external power source.Examination of the battery identified an area that appeared physically swollen.Once the depleted battery was replaced, the device could be interrogated and normal pacing and sensing were verified.The battery was forwarded on for detailed testing and it was found to have an internal short which resulted in the observed premature battery depletion.
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Search Alerts/Recalls
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