BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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Model Number DB-1216 |
Device Problem
Migration (4003)
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Patient Problems
Implant Pain (4561); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2022 |
Event Type
Injury
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Event Description
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It was reported that the clinical trial patient experienced a non-serious adverse event of spontaneous in situ rotation of their deep brain stimulator, dbs, implantable pulse generator, ipg, by 180 degrees.The patient underwent a revision procedure in which the ipg was repositioned.The event was assessed as causally related to the device.The event resolved and the ipg remains implanted.
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Event Description
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It was reported that the clinical trial patient experienced a non-serious adverse event of spontaneous in situ rotation of their deep brain stimulator, dbs, implantable pulse generator, ipg, by 180 degrees.The patient underwent a revision procedure in which the ipg was repositioned.The event was assessed as causally related to the device.The event resolved and the ipg remains implanted.
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Event Description
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It was reported that the clinical study patient experienced an adverse event of spontaneous in situ rotation of their deep brain stimulator (dbs) implantable pulse generator (ipg) by 180 degrees.The patient underwent a revision procedure in which the ipg was repositioned.The event was assessed as causally related to the device.The event resolved and the ipg remains implanted.Additional information was received that the patient was experiencing pain and tension due to the rotation of the ipg.The event was assessed as causally related to the procedure.
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