Model Number 37601 |
Device Problems
Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)
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Event Type
Injury
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Event Description
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It was reported that the battery had prematurely depleted.The battery had reached end of service in early (b)(6) 2014, which was indicated to be ¿early.¿ while testing impedances, the patient experienced a shocking sensation.Impedances were noted to be ¿ok¿ however.Pain and less than 50% therapy relief were noted as symptoms.A replacement was required as a result, but had not yet been performed.A follow up report will be sent if additional information is received.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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(b)(4).Device information was updated.Analysis of the implantable neurostimulator (ins) found no significant anomaly.The ins battery was at normal end of life and t elementary and output were okay.The battery reached end of life normally.The longevity estimate is 18.15 months to elective replacement indicator (eri) and 21.15 months to end of service (eos).According to the trace report the ins reached eri in 18.50 months and eos in 21.73 months.The manual states that "the electrode impedance measurement delivers a short sequence of pulses to each possible electrode pair, one after another.This can potentially cause transient unexpected effects.", which would explain the shocking/jolting.
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Manufacturer Narrative
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Concomitant: product id neu_unknown_lead, product type lead.(b)(4): analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.
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Event Description
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Additional information received indicated that the implantable neurostimulator and lead had been explanted.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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