MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number NEU_INS_STIMULATOR |
Device Problem
Unstable (1667)
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Patient Problems
Paresis (1998); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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The event date is unknown.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 the patient has had a total of four implants.Of the four implants, two that were implanted on their right side both have flipped.The first implant that was implanted on their right side was done in 2018 and the patient stated that they had the second one implanted in 2019.Then they mentioned that they are unsure if the physician had just done a revision or implanted a new implantable neurostimulator (ins) in 2019 and they do not have an id card with the serial numbers on them.The patient stated that the implants have both flipped shortly after having them implanted.They have not had any falls or trauma and no weight gain or loss when the implants flipped.When they turn sideways, the ins "flips over like a saucer" and they have to "put it back down".The patient added that they are having trouble navigating through the email because their right hand is "kind of paralyzed" and their left hand does not work very well.They were redirected to their healthcare provider (hcp) to further address the issue.Refer to manufacturer report #3004209178-2021-00809 for related device.
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Search Alerts/Recalls
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