MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); No Device Output (1435); Device Operates Differently Than Expected (2913)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Malaise (2359)
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Event Date 02/16/2018 |
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 consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient had surgery 2 weeks prior to the report to receive a new ins but the battery wouldn't work.The patient said the ins did not come on, the controller was almost full and the box inside of them was not turning on.The patient tried to use the controller during the call and read the message: cannot recharge the controller battery is too low to recharge the ins.The patient stated that stimulation stopped and they had been trying to turn it on since the friday prior to the report.The patient also reported that they thought their scar was infected; the patient went to the er on saturday and the doctor said it was infected and did blood work and urine, "it was all crazy." the patient then went to their healthcare professional (hcp) the day prior to the report and the pa at the hcp's office said it looked fine, they changed the dressing and did an x-ray; the patient went back to hcp in the day of the report and they said it looks like a totally different back.It was noted that the area of the infection was at the ins and the patient had a fever.The patient said they were in a whole lot of pain, they were nauseous,throwing up, their temp was 101.9 on saturday and they did not feel good; the patient said their temp was 102 on the morning of the report and they would see their hcp again on (b)(6).No further complications were reported/anticipated.
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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 healthcare professional.It was reported that patient was instructed by rep and stimulator functions.No infection was determined.Patient self-reported fever, but all measurements in office were normal.Keflex was given for few days and redness around incision resolved.All the reported issues resolved.Patient's weight information was provided.No further complications were reported/anticipated.
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