MDT SOFAMOR DANEK PUERTO RICO MFG ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 7425 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Sepsis (2067)
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Event Date 09/01/2003 |
Event Type
Injury
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Event Description
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Information was received from a patient with an implantable neurostimulator (ins) for complex regular pain syndrome type i.The patient reported having an infection and redness.Their nerve stimulator was infected and by (b)(6) 2003 they were septic.The infection was confirmed.The patient had a total system explant, they were in the hospital, and were on iv antibiotics for 2 weeks.The patient fully recovered from the infection.No further complications were reported/are anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a consumer regarding the patient.It was reported that in regards to the date that the spinal cord stimulation device came out and the type of infection that she had, all she knows is that she was septic and does not know the day the device was explanted.She went to the emergency room for 3 visits 10 days prior and they kept telling her that everything was fine, and the next thing that she knew, they told her that she had to come in right away because she was septic.She was hospitalized for 10 days.The hospital never returned the product.There were no further complications reported or anticipated.
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