Model Number D152 |
Device Problems
No Audible Alarm (1019); Noise, Audible (3273); Interrogation Problem (4017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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The product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) was difficult to interrogate.Additionally, it was noted that the patient with this icd heard beep tones.The patient was brought to the clinic, and the health care provider applied a magnet, but they did not hear any beeping tone, magnet response was not verified.Device replacement was recommended.Subsequently, a revision procedure was performed and the icd was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Although the device memory diagnostics demonstrated that the daily battery voltage measurements displayed an irregular pattern of discharge, the battery voltage level upon receipt in the laboratory remained sufficient to ensure therapy availability/delivery while the device was implanted.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a latent current leakage path within the battery itself, which resulted in a partial depletion of the battery.This behavior is caused by a latent electrical leakage path that develops over time between the anode and cathode within the device battery.In certain circumstances, lithium metal ions can re-plate to form clusters that may result in an internal current leakage.A design enhancement was implemented in 2013 to enlarge the physical barrier between the electrode layers to prevent current leakage in the area of the battery that is most often affected by this behavior.The product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) was difficult to interrogate.Additionally, it was noted that the patient with this icd heard beep tones.The patient was brought to the clinic, and the health care provider applied a magnet, but they did not hear any beeping tone, magnet response was not verified.Device replacement was recommended.Subsequently, a revision procedure was performed and the icd was explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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