Model Number 97714 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Charging Problem (2892)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of medical devices: product id 37751, serial# (b)(4), product type recharger.Information references the main component of the system.Other relevant device(s) are: product id: 37751, serial/lot #: (b)(4).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 consumer implanted with implantable neurostimulator (ins) for non-malignant pain.It was reported the charger was not charging from the wall.The patient stated he had it plugged in for the past 2 days and it was not charging.The patient was transferred to repair for replacement device.Additional information was received from the representative (b)(6) 2018.It was reported that there was a confirmed overdischarge.The reason recharging was not maintained was that there was an issue with recharging.The patient¿s recharger was not working, and they received a new one but they could never get it to charge like their old one.It was reviewed that multiple physician mode recharges (pmrs) may be required.It was reviewed to continue recharging and to clear power on reset as soon as the ins was 25% charged.The representative confirmed she successfully conducted a physician mode recharge, cleared the por and reviewed charging best practices.No further complications were reported/anticipated.
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Manufacturer Narrative
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Product id 37751 lot# serial# (b)(4) implanted: explanted: product type recharger review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Mdr decision corrected to not reportable. no additional supplementals required unless additional information received indicates reportable event.
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Search Alerts/Recalls
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