MEDTRONIC NEUROMODULATION RESUME TL; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 3986 |
Device Problems
Unable to Obtain Readings (1516); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Electric Shock (2554)
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Event Type
Injury
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Manufacturer Narrative
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The provided event information reasonably suggests the reported device pertained to one or both of the patient¿s implantable leads.A manufacturer¿s report was sent on each lead.Concomitant medical products: product id: 3986, serial# (b)(4), implanted: (b)(6) 1999, product type" lead.(b)(4).
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Event Description
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The consumer via the manufacturer representative reported that the patient experienced jolting sensations approximately at the lead location in the thoracic spine with stimulation turned up to the therapeutic voltage.The patient was also receiving appropriate stimulation down the legs, but the jolting sensation resulted in the patient not using stimulation.The event cause was unknown, and it was noted that the patient was a poor historian.Impedance checks revealed"???? on multiple combinations, and all other combinations were normal.The patient was reprogrammed with high-density-like settings.The implantable neurostimulator (ins) was at 45-90% use.It was also reported that revision of the full system was planned after testing.The patient's status was alive with no injury at the initial time of report.No outcome or troubleshooting/interventions were reported for this event.Further follow up is being conducted to obtain this information.If additional information becomes available, a follow up report will be sent.The patient's medical history included low back pain and multiple back operations.
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Search Alerts/Recalls
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