MEDTRONIC NEUROMODULATION PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 37702 |
Device Problems
Material Protrusion/Extrusion (2979); Positioning Problem (3009)
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Patient Problems
Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/23/2017 |
Event Type
Injury
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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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Information was received from a healthcare professional via a manufacturer representative as part of a clinical study regarding a patient implanted with a neurostimulator.It was reported that the patient was admitted to the hospital due to the fact that the corner of the stimulator started to protrude under the skin.There was no wound, infection, or any severe problem.The stimulator was repositioned from the back to the front.It was noted that the leads were in a good position, the system was still intact, and the system worked perfectly.The problem was resolved without any complications and the patient recovered completely.The event was noted to have a causal relationship to the investigational device.
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Manufacturer Narrative
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Foreign: the country of origin for the event was (b)(6).If information is provided in the future, a supplemental report will be issued.
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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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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