BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number DB-1140 |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problems
Fall (1848); Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)
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Event Date 12/01/2020 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced a fall unrelated to the device.The patient experienced trauma to the head, chest, and side of the ribs on the ipg left side.The patient was not receiving adequate pain relief.The physician suspected damage to the ipg.The patient underwent a revision procedure where the ipg was replaced.The patient was noted to be stable post-operatively.
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Manufacturer Narrative
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Device technical analysis: engineers inspected and analyzed this ipg upon receipt, the device passed all tests performed, and exhibited normal device characteristics.Investigation conclusion: based on all available information, engineers concluded that the reported event of the patient experiencing inadequate pain relief due to a non-device related fall could not be confirmed through laboratory analysis of the device, as the ipg passed all tests performed, and exhibited normal device characteristics.
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Event Description
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It was reported that the patient experienced a fall unrelated to the device.The patient experienced trauma to the head, chest, and side of the ribs on the ipg left side.The patient was not receiving adequate pain relief.The physician suspected damage to the ipg.The patient underwent a revision procedure where the ipg was replaced.The patient was noted to be stable post-operatively.
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