Model Number 8637-40 |
Device Problem
Premature Elective Replacement Indicator (1483)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/26/2017 |
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 healthcare provider regarding a patient who was receiving an unknown drug at an unknown concentration and dosage via an implantable pump for non-malignant pain.On 2017-oct-02, it was reported that the patient's pump had undergone premature eri.A non-critical alarm occurred and eri occurred was confirmed through telemetry.At the patient's last refill appointment on (b)(6) 2017, the eri was at 32 months.The pump was interrogated on (b)(4) 2017 and eri was shown to have occurred on (b)(6) 2017.No symptoms were reported.No further complications were reported.
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Manufacturer Narrative
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Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code because, although the device meets design specification, corrective actions are focused on enhancements to the design making this the closest code available with respect to this event.Analysis of the implantable infusion pump (serial # (b)(4)) revealed electrochemical migration across the electrical feed-through insulator which caused an electrical short.The electrical short resulted in a low battery reset/motor stall.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Interrogation of the pump found that it was delivering 20 mg/ml morphine at 3.495 mg/day and 340 mcg/ml clonidine at 59.42 mcg/day.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The device was returned to the manufacturer.
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Manufacturer Narrative
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Updated to reflect the report that a pump replacement is pending.Updated to reflect the information received on (b)(6) 2017.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 on (b)(6) 2017 from the patient's healthcare provider (hcp).It was reported that the patient's pump was refilled as scheduled.The cause of the premature eri was not determined.A replacement was not scheduled, but was pending.It was confirmed that the pump would be returned to the manufacturer once it is explanted.The patient's weight was provided.The issue was not considered resolved as replacement was pending.No further complications were reported.
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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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Additional information was received from a manufacturer's representative (rep).It was reported that the pump was replaced on (b)(6)2017 and would be sent back to the manufacturer for analysis.
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Search Alerts/Recalls
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