Model Number 3664 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fever (1858); Post Operative Wound Infection (2446); Implant Pain (4561)
|
Event Date 09/28/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.During processing of this incident, attempts were made to obtain complete event information.
|
|
Event Description
|
It was reported that the patient had an infection at the ipg site.As a result, patient experienced fever and soreness at the ipg site.Patient was hospitalized.Additionally, the patient¿s entire system was explanted in (b)(6) 2021 (exact explant date unknown) to address the reported infection.
|
|
Event Description
|
Additional information received indicates that the patient¿s entire system was explanted (b)(6) 2021 to address the reported infection.The patient is on iv antibiotics to treat the staph infection.The infection is resolving.
|
|
Event Description
|
Additional information received indicates that the infection has not resolved and patient is still on oral antibiotics.
|
|
Event Description
|
Additional information received indicates that the infection has cleared up and the patient is still on oral antibiotics.
|
|
Manufacturer Narrative
|
A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
|
|
Search Alerts/Recalls
|