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Model Number M0063901050 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that there a was a tear in the packaging during unpacking on an unknown date.During unpacking, the shipping box was opened from delivery and found a tear in the packaging compromising the sterility of the device.There were no patient involvement.
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Search Alerts/Recalls
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