BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-1232 |
Device Problems
Charging Problem (2892); Positioning Problem (3009); Wireless Communication Problem (3283); Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: exact date unknown, event occurred couple of days ago from the date the manufacturer was made aware.
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Event Description
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It was reported that the patient got a communication failed message, experienced difficulty and frequent charging of the ipg due to ipg migration that was confirmed via x-ray.Database analysis of the battery discharge shows signs of poor charger to ipg coupling that suggests a poor ipg depth or orientation.The patient underwent a revision procedure wherein the ipg was changed to a non-rechargeable one and patient was doing well postoperatively.The explanted ipg will not be returned per hospital policy.
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Search Alerts/Recalls
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