BOSTON SCIENTIFIC CORPORATION MAESTRO 4000 CONTROLLER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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Model Number 86248 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
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Event Description
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It was reported that the maestro 4000 generator output was fluctuating, usually output is on the weak side.No patient complications were reported.
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Search Alerts/Recalls
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