Model Number 37714 |
Device Problems
Loss of Power (1475); Delayed Charge Time (2586); Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
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Event Date 06/21/2013 |
Event Type
malfunction
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Manufacturer Narrative
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Occupation: non-healthcare professional.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 patient with an implantable neurostimulator (ins) for non-malignant pain and failed back surgery syndrome.It was reported that the patient had the ins reprogrammed a couple times and it helps fora while but then the pain returns.The patient stated they have always had pain since they got the device but the ins has helped some.The patient said their back and legs hurt so bad that they can't do much.The patient stated the pain was never fully taken away by the ins but the pain in their legs and back had gotten worse a couple months back.The patient also reported that it takes forever to charge the ins.The patient said sometimes they lay in bed and it takes all day to charge.The patient mentioned that the ins has always hurt them, there was pain at the ins site and it protrudes from their side.The patient said they discussed this with their healthcare professional and mentioned eventually they can get a replacement ins.No further complications were reported/anticipated.(b)(4).
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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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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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It was reported that once a health care provider (hcp) told the patient that the device may have been put in a bad location and that the patient should wait until they needed to have their current ins replaced.The consumer's other hcp told the patient to have the ins removed.No further complications were reported.
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Search Alerts/Recalls
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