Model Number 97702 |
Device Problems
Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)
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Event Type
Injury
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Manufacturer Narrative
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Report source: (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient reported a neurostimulation failure that occurred after airport staff came close to the battery with a handheld scanner leading to an immediate stop in stimulation and the "contact your doctor" error message.The implantable neurostimulator (ins) turned off due to the security gate.Due to the failure of the stimulation, the patient was unable to walk normally and missed the flight as it was too far to walk to the gate (just barely missed it).The patient suffered mental and physical damage as the battery has only been implanted for three months and now is already run down again by something they brushed off as being normal.The company representative (rep) followed up with the patient's pain clinic where she was being treated.According to the pain clinic this was normal elective replacement indicator (eri) that has occurred quite rapidly as a result of the use of hd stimulation.The clinic suspects the ins failure when the handheld scanner used at the airport was a coincidence.The patient experienced more pain due to the depleted ins.The ins was replaced with a rechargeable ins and the patient status was okay.
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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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Search Alerts/Recalls
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