Model Number 3116 |
Device Problems
Disconnection (1171); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 435135, serial#: (b)(4), implanted: (b)(6) 2010, product type: lead.Product id: 435135, serial#: (b)(4), implanted: (b)(6) 2010, product type: lead.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 (con) regarding a patient who was implanted with a neurostimulator (ins) for gastric stimulation.It was reported that the patient¿s device was acting funny so they went to the hospital.While there, their healthcare professional (hcp) determined that the patient¿s device had ¿tripped off¿ somehow, but they didn¿t know how.The patient noted they hadn¿t been around any electromagnetic interference (emi) or had any falls.While at the hospital, the patient stated they were attacked on the (b)(6) (unknown month).After they were attacked, they started having issues with the device so they had an x-ray.The x-ray determined that the lead was dislodged from the device.The patient needed surgery to resolve this, but needed to contact a manufacturer representative (rep) prior to having surgery.The patient noted they could not eat or drink at all when the device was off.The next day, it was reported that the patient had a shocking feeling in their abdomen.A belt was used across the patient¿s abdomen, causing pain and shocking.It was also noted that a device interrogation found the lead impedance was out of range around (b)(6) 2020 and (b)(6) 2020.The device was reprogrammed and offered to be turned off by the hcp, but the patient refused to turn the device off because they did not want symptom return.Surgical intervention was planned in the coming weeks.No further complications were reported or anticipated.
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Search Alerts/Recalls
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