MEDTRONIC NEUROMODULATION SOLETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 7426 |
Device Problem
Malposition of Device (2616)
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Patient Problems
Complaint, Ill-Defined (2331); Shaking/Tremors (2515)
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Event Type
Injury
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Event Description
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It was reported that around (b)(6) 2013, the patient¿s symptoms had gotten worse, they had tremor on their right side, and their limbs were distorted.After the implantable neurostimulator (ins) was implanted on the right side the patient¿s symptoms on their left side were controlled well.The patient was then implanted with an ins on their left side to control the symptoms on the patient¿s right side.On the same day the patient¿s healthcare professional adjusted the target position of the right ins.Following surgery the patient felt the left ins was heavier than the right ins, but the symptoms were controlled well.On (b)(6) 2014, the patient¿s limbs were trembling, their joints were distorted and their symptoms had gotten worse.The patient was reprogrammed on (b)(6) 2014, but their symptoms did not improve.Follow up with a manufacturing representative indicated that the cause of the event was not determined and it was unknown if intervention was done or if the patient was receiving effective therapy.No interventions or outcome were reported regarding this event.Additional information could not be obtained.Should additional information be received the event will be updated.Refer to manufacturer report #3004209178-2014-18342.
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Manufacturer Narrative
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Concomitant product: product id 7426, serial # (b)(4), implanted: (b)(6) 2010, product type implantable neurostimulator.(b)(4).
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Search Alerts/Recalls
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