Model Number 8637-40 |
Device Problems
Pumping Stopped (1503); Data Problem (3196)
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Patient Problems
Pain (1994); Malaise (2359)
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Event Date 09/24/2018 |
Event Type
malfunction
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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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Event Description
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Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving an unknown drug at unknown dose and concentration via intrathecal drug delivery pump.The indication for use was noted as non-malignant pain and trunk/limbs chronic/intract pain.It was reported that the patient had been out hunting and heard the pump alarm.The patient noted a code on his personal therapy manager (ptm) that showed 8477 (err_pump_critical_memory).Nothing showed on telemetry when interrogating the pump with a clinician programmer.The patient was feeling sick and had a sharp increase in pain and they had to "carry him out." the date of the event was (b)(6) 2018.There were no further complications reported at this time.Additional information was received from a manufacturer representative.It was clarified that in regards to they had to "carry him out," the patient did not feel well enough to walk out or drive his atv.In regards to no event appearing in telemetry logs, it was clarified that a memory loss and motor stall were in the events.The pump was interrogated, the motor stall cleared; however, it stalled again and the pump had been replaced.There were no further complications reported at this time.
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Manufacturer Narrative
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Analysis of the implantable pump (serial # (b)(4)) identified residue in the motor gear train and wearing on the shaft of the gear or the rotor.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from a manufacturer representative.It was reported that the pump was explanted on (b)(6) 2018.It was programmed to deliver ropivacaine (10mg/ml at 4.254mg/day) and morphine sulfate (3mg/ml at 1.2761mg/day).The pump was removed due to the sudden loss of therapy.A rotor study and dye study were not performed.There were no further complications reported at this time.
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Search Alerts/Recalls
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