BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Model Number F103 |
Device Problem
Defibrillation/Stimulation Problem (1573)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/14/2022 |
Event Type
Injury
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) had reached elective replacement indicator (eri) on (b)(6) 2022.Then, in (b)(6) 2022 the patient experienced ventricular tachycardia (vt), however, no therapy was delivered from the icd.Reportedly, the vt episode lasted 17 minutes and the patient called an ambulance.When the ambulance arrived, the episode was already over and no further action was taken.The icd device was then explanted and replaced due to reaching eri status.No additional adverse patient effects were reported.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) had reached elective replacement indicator (eri) on (b)(6) 2022.Then, in may 14th, 2022 the patient experienced ventricular tachycardia (vt), however, no therapy was delivered from the icd.Reportedly, the vt episode lasted 17 minutes and the patient called an ambulance.When the ambulance arrived, the episode was already over and no further action was taken.The icd device was then explanted and replaced due to reaching eri status.No additional adverse patient effects were reported.The device is expected to be returned for analysis.Additional information received indicates the device had not yet been returned as it had to be collected from the hospital, however, it is still expected to be returned for analysis.
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Manufacturer Narrative
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The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations of failure to shock or properly shock.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) had reached elective replacement indicator (eri) on (b)(6) 2022.Then, in (b)(6) 2022 the patient experienced ventricular tachycardia (vt), however, no therapy was delivered from the icd.Reportedly, the vt episode lasted 17 minutes and the patient called an ambulance.When the ambulance arrived, the episode was already over and no further action was taken.The icd device was then explanted and replaced due to reaching eri status.No additional adverse patient effects were reported.The device is expected to be returned for analysis.The device was returned for analysis.
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