Model Number 97713 |
Device Problem
Degraded (1153)
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Patient Problem
Discomfort (2330)
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Event Date 02/01/2017 |
Event Type
malfunction
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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 about a patient with an implantable neurostimulator (ins) for chronic low back pain and spinal pain.It was reported that the patient¿s device had gradually become ¿caustic¿ and uncomfortable.The patient stated that they could not use their device at night anymore when they needed it most because it had gotten worse.A list of physicians in the patient¿s area were provided to the patient so they could have their device adjusted as it was reported that the patient lived in (b)(6) for the winters.
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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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Additional information was received from the patient.It was reported programming adjustments were made on (b)(6) 2017.Currently, the issue of the device gradually becoming caustic and uncomfortable had been resolved.However, the patient noted that over time, new adjustments will be needed and that is just the way it works.The issue of the device becoming caustic and uncomfortable happens as time goes by.No further complications were anticipated/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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Search Alerts/Recalls
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