Model Number 8637 |
Device Problems
Electromagnetic Interference (1194); Inappropriate or Unexpected Reset (2959); Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 foreign healthcare provider (hcp) regarding a patient who was receiving an unknown drug via an implantable pump for an unknown indication for use.The hcp called technical services about a motor stall after mri.Technical services talked the hcp through steps on checking for recovery.Later, the hcp called back stating the pump was in safe state and they were unable to program the pump back to simple continuous mode.The hcp could see multiple low battery resets in the logs.The pump had been implanted for over six years.There were no reported symptoms.No complications were reported.
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Manufacturer Narrative
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Review of additional information revealed the information contained in this report has been previously reported in regulatory report 3004209178-2017-24719.All further information regarding this event will be reported under that reference number.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Review of additional information revealed the information contained in this report has been previously reported in regulatory report 3004209178-2017-24719.All further information regarding this event will be reported under that reference number.
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Search Alerts/Recalls
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