BOSTON SCIENTIFIC CORPORATION INTERMEDICS PRODUCT; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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Device Problem
Difficult to Insert (1316)
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Patient Problems
Dyspnea (1816); Perforation (2001); Pneumothorax (2012)
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Event Date 06/14/2023 |
Event Type
Injury
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Event Description
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It was reported that during implant, it was difficult to obtain venous access and multiple attempts were required.The device system implant was ultimately completed successfully and the pocket closed.Then, upon transferring the patient onto the bed, the patient experienced sudden shortness of breath.The patient went to recovery and was able to talk and converse with assistance from the breathing mask.Chest x-ray was performed and small left-sided pneumothorax was confirmed by a dark area on the upper left side of the chest wall.It was then mentioned that the pneumothorax was suspected to be caused by multiple attempts at obtaining vascular access with the introducer needle.The patient was then transferred to the intensive care unit (icu) for treatment, and a chest drain was performed and then the patient was transferred back to the icu for continuous monitoring.The device system remains in service.The patient was discharged from the hospital and no additional adverse patient effects were reported.
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Event Description
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It was reported that during implant, it was difficult to obtain venous access and multiple attempts were required.The device system implant was ultimately completed successfully and the pocket closed.Then, upon transferring the patient onto the bed, the patient experienced sudden shortness of breath.The patient went to recovery and was able to talk and converse with assistance from the breathing mask.Chest x-ray was performed and small left-sided pneumothorax was confirmed by a dark area on the upper left side of the chest wall.It was then mentioned that the pneumothorax was suspected to be caused by multiple attempts at obtaining vascular access to implant the above-referenced lead.The patient was then transferred to the intensive care unit (icu) for treatment, and a chest drain was performed and then the patient was transferred back to the icu for continuous monitoring.The device system remains in service.The patient was discharged from the hospital and no additional adverse patient effects were reported.
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Manufacturer Narrative
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Correction: fields b2 (outcomes attrib to adv event) and d.(suspect medical device) were updated.
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