Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Itching Sensation (1943); Post Operative Wound Infection (2446)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 4 of 5: reference mfr report#1627487-2018-10470, reference mfr report#3006705815-2018-02806, reference mfr report#3006705815-2018-02807, reference mfr report#1627487-2018-10647.It was reported that the at the follow-up visit post implant (wound care checkup) patient reported redness, burning and extreme itching at both the lead and ipg surgical sites.Reportedly, no drainage, fever or chills were reported.The patient was prescribed prophylactic antibiotic as a precaution for infection or cellulitis, but the physician believed it was more likely an allergic reaction to the surgical glue and therefore prescribed anti-histaminic.Follow up visit identified that patient symptoms were reduced.Antibiotic course completed and no additional medications were prescribed.Patient symptoms have reportedly resolved.
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Event Description
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Device 4 of 5: reference mfr report#1627487-2018-10470; reference mfr report#3006705815-2018-02806; reference mfr report#3006705815-2018-02807; reference mfr report#1627487-2018-10647.Additional information received identified that patient was admitted to the emergency room (er) (b)(6) 2018 night for further evaluation for possible infection.Reportedly, patient had fever with chills of 102 degrees for 2 to 3 days and unrelenting headache prior to the er visit.Reportedly, patient¿s wife noted a small swelling near the incision (site unknown).Patient underwent a ct scan of the thoracic spine which was inconclusive.Patient is currently admitted and is on antibiotics.
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Event Description
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Device 4 of 5.Reference mfr report#1627487-2018-10470.Reference mfr report#3006705815-2018-02806.Reference mfr report#3006705815-2018-02807.Reference mfr report#1627487-2018-10647.Additional information revealed that patient had suffered a staph infection.As a result, the patient's system was explanted on (b)(6) 2018.Patient is currently being treated by an infectious disease physician.
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Search Alerts/Recalls
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