Model Number T135 |
Device Problem
Defective Device (2588)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) was not functional.Healthcare professional (hcp) asked boston scientific technical services (ts) if the device is magnetic resonance imaging (mri) conditional.Ts then confirmed device is not mri conditional.To date, the device remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) was not functional.Health care professional (hcp) asked boston scientific technical services (ts) if the device is magnetic resonance imaging (mri) conditional.Ts then confirmed device is not mri conditional.To date, the device remains in service.No adverse patient effects were reported.Additional information was received indicating that the device was explanted and was returned to the laboratory for further analysis.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) was not functional.Health care professional (hcp) asked boston scientific technical services (ts) if the device is magnetic resonance imaging (mri) conditional.Ts then confirmed device is not mri conditional.To date, the device remains in service.No adverse patient effects were reported.Additional information was received indicating that the device was explanted and was returned to the laboratory for further analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.Upon receipt at our post market quality assurance laboratory, an ohm meter was used to verify that the defibrillation output bridge was intact.Resistance across the df+ to the df- was measured at 132.7 kohms, which is normal, and confirms that the output bridge is intact and therapy availability was not compromised.Manual therapy availability testing was unable to be performed, as the device has reached bex due to a normally depleted battery.No allegation from the field has been made against device functionality at explant.The device has been implanted for approximately 16.7 years; far exceeding nominal expected longevity.Supplemental correction to correction section h1 type of reportable event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.Upon receipt at our post market quality assurance laboratory, an ohm meter was used to verify that the defibrillation output bridge was intact.Resistance across the df+ to the df- was measured at 132.7 kohms, which is normal, and confirms that the output bridge is intact and therapy availability was not compromised.Manual therapy availability testing was unable to be performed, as the device has reached bex due to a normally depleted battery.No allegation from the field has been made against device functionality at explant.The device has been implanted for approximately 16.7 years; far exceeding nominal expected longevity.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) was not functional.Health care professional (hcp) asked boston scientific technical services (ts) if the device is magnetic resonance imaging (mri) conditional.Ts then confirmed device is not mri conditional.To date, the device remains in service.No adverse patient effects were reported.Additional information was received indicating that the device was explanted and was returned to the laboratory for further analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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