Model Number PM2272 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2024 |
Event Type
Injury
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Event Description
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It was reported that the device was explanted and replaced prophylactically as it is subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action issued on 20 july 2022, which applies to a subset of devices distributed and implanted outside of the united states.The patient was in stable condition.
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Event Description
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It was reported that the device was pending prophylactic explant as it is subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action issued on (b)(6) 2022, which applies to a subset of devices distributed and implanted outside of the united states.The patient was in stable condition.
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Manufacturer Narrative
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Correction: upon review of new information, the pulse generator should not have been submitted as a medical device report as the device currently remains implanted and is pending explant.No malfunction has been observed on the device.
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Event Description
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It was reported that the device was explanted and replaced prophylactically as it is subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action issued on (b)(6) 2022, which applies to a subset of devices distributed and implanted outside of the united states.The patient was in stable condition.
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Search Alerts/Recalls
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