Model Number 103 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Pain (1994); Swelling (2091)
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Event Date 07/11/2015 |
Event Type
Injury
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Manufacturer Narrative
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Type of device product code: this device was implanted to treat chronic heart failure, which is currently an unapproved indication that is currently undergoing active clinical trial.
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Event Description
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Adverse event form received on (b)(6) 2015 reported that this patient had an occurrence of post-op infection causing pain and swelling at the site.On (b)(6) 2015 the patient presented with a complaint of pain at the surgery site with two episodes of fever for the past 3 days.Upon examination, mild infection at the surgery site was found.Patient was started with oral antibiotics for the infection.The outcome of the event is that it is recovering and the seriousness was considered based on initial hospitalization and intervention required to prevent a serious outcome (medication).The infection is a post-op infection that occurred less than 1 week after implantation.No additional relevant information has been received to date.
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Event Description
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Updates on 03/10/2016 states that the outcome of the infection is recovered with sequelae on (b)(6) 2015.He was provided with oral antibiotics and later switched to iv antibiotics.
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Manufacturer Narrative
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Initial mdr and follow-up report #1 inadvertently omitted information about the location of the infection.
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Event Description
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The infection was present at the site of the chest (site of the pulse generator) and the neck (site of electrode).
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Search Alerts/Recalls
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