Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 08/12/2022 |
Event Type
Injury
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Event Description
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Related manufacturer reference number: 3006705815-2022-16564, 3006705815-2022-16565, 3006705815-2022-16566, 1627487-2022-04849.It was reported the patient experienced an infection at the ipg site.The infection was tracking towards the lead site and the entire system was explanted.Patient was prescribed oral antibiotics.
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Additional information received indicates the infection has resolved.
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Manufacturer Narrative
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An event of infection was reported to abbott.It was conveyed that the infection originates at the ipg and lead site(s).The entire system was explanted; however, no explanted products were returned for analysis.The patient was treated with antibiotics and the infection has resolved.As a result, a device history record was performed to review and confirm the sterility of the ipg and lead(s).Based on the documents reviewed, the source of the infection remains unknown.
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Search Alerts/Recalls
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