Model Number 97714 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 977c165, serial (b)(4), implanted: (b)(6) 2017, product type: lead.The main component of the system.Other relevant device(s) are: product id: 977c165, serial/lot (b)(4), ubd: 13-oct-2020, if information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient was in the hospital due to an infection.The infection was confirmed.The rep thought the patient was in the hospital for about 12 days due to infection of the paddle lead.No further complications were reported.
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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 manufacturer representative.It was reported that there was no infection per the mri that was taken.It was reported that the patient had a "superficial stitch abcess" and no deeper abscess as determined by a ct scan.The doctor offered to explant the patient's paddle lead and they declined.It was noted that the patient was treated with antibiotics.No further complications 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 manufacturer representative.It was reported that the patient's scs system was explanted.The date of the explant was unknown.No further complications are anticipated.
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Search Alerts/Recalls
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