Model Number 102 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ecchymosis (1818); Edema (1820)
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Event Date 09/29/2006 |
Event Type
Injury
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Event Description
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It was reported by the caregiver that the patient's implant site was so swelled up after the generator replacement surgery that the patient was hospitalized overnight, even though it was originally supposed to be an outpatient procedure.The caregiver reported that a week later it was still swollen and they stuck it with a needle, expecting fluid to drain out, but nothing came out.The caregiver stated that the surgeon had "no idea what the swelling was about and to this day doesn't know".
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Manufacturer Narrative
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Report source, corrected data: initial report inadvertently selected other and input 'caregiver' instead of selecting consumer.
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Event Description
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It was reported via clinic notes that after a period of time following the surgery, fluid was extracted from around the wound site and was sent to the lab for evaluation of the cultures.It was noted that the swilling was nonpurulent and there was no drainage nor had the patient been having any fever.Clinic notes from a later date indicated that both incisions were in very good condition and there was no fluctuance, redness, or apparent tenderness.The surgical notes indicated that the incision sites were irrigated with bacitracin solution.
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Manufacturer Narrative
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Describe event or problem, corrected data: follow-up report #01 inadvertently left out the information regarding the reported hematoma.(b)(4).
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Event Description
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The clinic notes received also contained notes from a second physician that indicated that the patient had a hematoma that was beneath the patient's skin, not the pectoral muscle, that was still quite apparent.It was noted that the yellowish discoloration had spread over the chest, down to the left elbow and over the clavicle.It was noted that the hematoma area was fluctuant, but did not feel hot and was not tender.The physician attempted to aspirate the area was only able to aspirate only 2 to 3 cc of blood, which was sent for culture.It is unclear if the reference of swelling from one physician was the same as hematoma referenced by the second physician.
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Search Alerts/Recalls
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