Model Number MN10450-50A |
Device Problems
Material Fragmentation (1261); Use of Device Problem (1670)
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Patient Problems
Failure of Implant (1924); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2023 |
Event Type
Injury
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Manufacturer Narrative
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During processing of this incident, attempts were made to obtain complete event and patient information.Further information was requested but not received.
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Event Description
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Related manufacturer reference number: 1627487-2023-03405.It was reported that scar tissue prevented the patient's s1 leads from being completely removed during a surgical procedure intended to explant the patient's sytem on (b)(6) 2023.Surgical intervention may be pending to address the issue.
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Event Description
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It was reported that the physician cut the leads when they could not be removed completely, leaving a portion of the leads implanted.
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Manufacturer Narrative
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Corrected data: b5, clinical code, impact code, and medical device problem code corrected to reflect updated information.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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