Model Number 37612 |
Device Problems
Break (1069); Failure to Charge (1085); Battery Problem (2885); Connection Problem (2900); Material Integrity Problem (2978); Insufficient Information (3190)
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Patient Problems
Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)
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Event Date 07/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 37761, serial# unknown, product type: recharger.Other relevant device(s) are: product id: 37761, serial/lot #: unknown.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 the treatment of essential tremor and movement disorders.It was reported the implantable neurostimulator recharger (insr) would not charge and the connector pin was broken.The patent stated that he had nothing but problems when it stopped working.The patient clarified he went crazy and could not walk or do anything.The patient confirmed this was because the ins battery depleted but then later noted he was not sure if the ins battery was depleted.No out of box failure was reported.A replacement desktop charger was sent.No medical/therapy problems or further complications were reported or 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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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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Manufacturer Narrative
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Concomitant medical products: product id: 37761, serial# unknown, product type: recharger.(b)(4).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: it was reported that the patient and patient's step-son had called in stating similar info to previous reports.The recharger device was not working and cause the device to go dead.The patient could hardly move.The patient was not originally able to be transferred due to the high volume of calls.There were no further complications reported.
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Manufacturer Narrative
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Concomitant medical products: product id 37761, serial# unknown, product type recharger.Analysis found that the connector pin was broken.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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