Model Number NEU_INS_STIMULATOR |
Device Problems
Migration or Expulsion of Device (1395); Unintended Collision (1429); Delayed Charge Time (2586); Battery Problem (2885); Unintended Movement (3026); Insufficient Information (3190)
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Patient Problems
Fall (1848); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2014 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_lead, serial# unknown, product type: lead.The main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.Date of event: date is approximate.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 consumer regarding a patient with an implantable neurostimulator (ins).It was reported that the patient had a fall which caused damage to the ins.The patient stated the wires moved in front of their spinal cord.The patient also stated they had issues with it taking forever to charge.No symptoms were reported.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 the patient.It was reported that in 2014-2015 the patient had a fall down the stairs (a really bad fall, went into the wall and it damaged the right side of their body).The patient said the wires kept moving as the used the thinner leads that were mri compatible.The patient stated that the surgical lead would continue to roll down the spinal cord as the leads were too thin and the leads were just replaced when the ins was replaced due to end of service (eos).The patient said the healthcare professional (hcp) tried everything and the surgery took longer as the hcp tried everything in their power to keep the device in place.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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Search Alerts/Recalls
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