MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97702 |
Device Problems
Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)
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Patient Problem
Dizziness (2194)
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Event Date 06/01/2017 |
Event Type
malfunction
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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 consumer regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that on (b)(6) 2017, the patient felt like she was passing out, and supposedly when the patient¿s pacemaker was checked, they noted interference.When the spinal cord stimulation was turned off, the patient was feeling fine.They also noted the experience once in (b)(6) of 2017.It was unknown if there was testing for interference during implantation.The pacemaker is on the left chest, and the implantable neurostimulator is in the left buttocks and the lead is at t8-t10, with electrodes 4+, 5-, 6-.There were no further complications 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 (rep) on november 10, 207.It was reported that no changes were made to the programming and the patient was referred to her cardiologist to possible adjust the sensitivity of her pacemaker.It was unknown if the interference was mutual or not, it is unknown how the devices were affected by the interference, the cause of the interference was unknown and it was unknown if the issues resolved.There were no further complications reported or anticipated.
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