Model Number 8637-40 |
Device Problem
Premature End-of-Life Indicator (1480)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 02/15/2017 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for non-malignant pain and failed back surgery syndrome.It was unknown what drug was in the pump.It was reported an alarm was heard and confirmed by telemetry.An end of service (eos) alarm occurred, but early replacement indicator (eri) wasn¿t due reportedly for 13 months.Reported symptoms included withdrawal.The pump was replaced.The change in therapy/symptoms was considered sudden.
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Event Description
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Additional information was received from a healthcare provider (hcp) through a manufacturing representative.Conflicting information was reported that the patient was going to be scheduled for a replacement, but the manufacturing representative did not have a date.
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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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