Model Number L331 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); No Code Available (3191)
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Event Date 06/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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It was reported that this patient with pacemaker device might have allergy to the device as the patient had swelling and pain at the site and down thru arm.Boston scientific technical services (ts) then provide list of all direct contacting materials.This device remains in service.No adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, the allegation was not confirmed.The device passed mechanical and electrical tests and is functioning normally.Patient code 3191 captures the reportable event of surgery.
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Event Description
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It was reported that this patient with pacemaker device might have allergy to the device as the patient had swelling and pain at the site and down thru arm.Boston scientific technical services (ts) then provide list of all direct contacting materials.This was explanted.No adverse patient effects were reported.
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Search Alerts/Recalls
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