BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number DB-1140 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 10/10/2022 |
Event Type
Injury
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Event Description
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It was reported the patient experienced cramps that emitted a shock-like sensation as the implantable pulse generator (ipg) neared the end of life.Additionally, the physician assessed the ipg had depleted early, as the device was estimated to have a lifespan of five years based on the energy usage index (eui); however, the ipg reached the end of life (eol) after four years.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.
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Manufacturer Narrative
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The returned ipg passed the functional test, and the electrical test revealed normal device characteristics.Stimulation was monitored on an oscilloscope and the output was consistent and correct on all electrodes.Current leakage tests and residual gas analysis verified no loss of electric current from the ipg case.Impedance measurements with known good leads were within the expected range.Additionally, the ipg battery voltage was above the elective removal indicator (eri) threshold.Based on the patient stimulation settings, the energy use index (eui) indicates a projected battery lifespan of approximately 4.5 years.The ipg was in service for 3 years, 9 months, and 4 weeks when it was explanted; and engineers did not observe the end of life message during analysis of the device.Therefore, although it was reported that the ipg had reached eol and was removed after less than 4 years of service, engineers found no evidence of early battery depletion as all tests were passed, battery voltage was above eri threshold, and the eol message was not observed.Additionally, the patient experiencing cramping is a known risk of use with the dbs system as stated in the instructions for use.
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Event Description
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It was reported the patient experienced cramps that emitted a shock-like sensation as the implantable pulse generator (ipg) neared the end of life.Additionally, the physician assessed the ipg had depleted early, as the device was estimated to have a lifespan of five years based on the energy usage index (eui); however, the ipg reached the end of life (eol) after four years.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.
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