MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 37702 |
Device Problems
Device Operates Differently Than Expected (2913); Improper Device Output (2953)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 04/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 97740, serial# (b)(4), product type: programmer, patient.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 regarding a patient with an implantable neurostimulator (ins), and it was reported that there was poor communication with the patient programmer.The patient stated that during the night the ins "went bonkers" and the patient was unable to turn it off with the patient programmer.New batteries were tried, and the issue was not resolved.The patient was able to turn the ins off with the patient programmer by not using the external antenna.The patient did not turn the ins on because he was worried about not being able to turn it off.The patient checked that their antenna was secure and attempted to interrogate and could not.The patient tried interrogating using the programmer directly and was unable to.Patient was issued a new patient programmer.There were no reported complications and no further complications were expected.Patient was implanted for non-malignant pain and failed back surgery syndrome.
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Search Alerts/Recalls
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