Model Number 4712 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Implant Pain (4561)
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Event Date 01/23/2023 |
Event Type
Injury
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Event Description
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It was reported that during the implant procedure for the subcutaneous implantable cardioverter defibrillator (s-icd) system, the physician believed the tunneling tool may have gotten between the patient's ribs.The physician stopped, pulled back, and evaluated the patient's vitals and took multiple fluoroscopy views.No injury was observed, but the patient complained of soreness in the sternal area after the procedure.The physician believed too steep of an angle was used in an attempt to stay directly on the sternum.The final system placement was excellent and remains in service without further complication.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.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The tunneling tool entered the thoracic space during the procedure.Please refer to the section b5 for more information regarding the specific circumstances of this event.
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Event Description
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It was reported that during the implant procedure for the subcutaneous implantable cardioverter defibrillator (s-icd) system, the physician believed the tunneling tool may have gotten between the patient's ribs.The physician stopped, pulled back, and evaluated the patient's vitals and took multiple fluoroscopy views.No injury was observed, but the patient complained of soreness in the sternal area after the procedure.The physician believed too steep of an angle was used in an attempt to stay directly on the sternum.The final system placement was excellent and remains in service without further complication.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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