MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 37711 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Complaint, Ill-Defined (2331); Malaise (2359); Loss of consciousness (2418)
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Event Type
Injury
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome.The patient reported that she had been in the hospital for ¿like 3 months, my pain had been really bad to where they were going to have a new ins put in because the ins wasn¿t getting my pain where i need it.¿ the patient reported that her pain had been really bad for ¿years and years¿ but it got really bad ¿about 3 months ago and i¿m in bed all the time and i throw up because of the pain, and i¿m not on pain medicine no more because pain management won¿t give it to me no more so it¿s really caused me to be sick as far as nauseated and i¿m not able to function.¿ the patient also reported that she ¿passed out two weeks ago today and fell and i hit my head on the granite and it looked like i broke my nose, because of the pain and i was so sick and i had to go to the hospital.¿ 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 consumer.It was reported that the circumstances leading to the patients increase in pain was that they are no longer on pain medication for their chronic pain, as they got a new healthcare provider (hcp), because theirs closed, but the new hcp doesn't give out pain medication.The patient stated that their pain is debilitating.The steps being taken to resolve the increase in pain is that the patient is they are waiting to get a new ins, but they can't get in to see the doctor until (b)(6).The issues are not resolved yet, but they are getting a new ins and it will help them a lot more.No further complications were reported.
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Search Alerts/Recalls
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