Model Number 8637-20 |
Device Problem
Pumping Stopped (1503)
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Patient Problems
Dyspnea (1816); Therapeutic Response, Decreased (2271); Anxiety (2328); Sweating (2444)
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Event Date 04/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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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On (b)(6) 2017, information was received from a foreign healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving baclofen (2000 mcg/ml, 1000 mcg/day) via an implantable pump for an unknown indication for use.On (b)(6) 2017, the pump stopped working 15 months before elective replacement indicator (eri).The pump gave a critical alarm for about 3 hours and it was stated, "the pump doesn't start working during this period" (also reported as motor stop).A pump replacement occurred on (b)(6) 2017, reported as a partial explant, before the patient "get further withdrawal symptoms".The status of the patient was stated to be alive and with no injury.The event was considered to be resolved as of (b)(6) 2017.No further complications were reported/expected.
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Manufacturer Narrative
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(b)(4).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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On 2017-apr-25, additional information was received from a foreign manufacturer representative (rep).It was confirmed the pump was explanted on (b)(6) 2017.The critical alarm first occurred on (b)(6) 2017.The previous statement "the pump gave a critical alarm for about 3 hours" was clarified that the alarm began in the morning and still persisted until the pump explanation.It was also reported that after 3 hours of the pump alarming, the patient first got withdrawal symptoms, specifically shortness of breath, nervousness and sweats.When the patient first got their withdrawal symptoms, a pump replacement was "arranged immediately".Clarification to "pump stops working 15 months before eri" was attempted and it was stated, "it only means that the motor stopped".It was reported the patient was doing well again.
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Manufacturer Narrative
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Analysis of the pump (sn; (b)(4)) found motor gear train anomalies; corrosion and/or wear and/or lubrication and the stall was due to shaft-bearing.Analysis identified residue in the motor gear train that contributed to the motor stall.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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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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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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