Model Number MN10450-50A |
Device Problems
Migration or Expulsion of Device (1395); Migration (4003)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 06/18/2020 |
Event Type
Injury
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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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Event Description
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Related manufacturer reference number 1627487-2021-00288 and 1627487-2021-00289 it was reported the patient was unable to feel stimulation with the lead implanted at the s1 vertebral level, even with the amplitude being at maximum level.Amplitude for the leads implanted at the l4 and l5 vertebral levels was increased and the patient was able to receive therapy.Diagnostics did not reveal any impedance issues.All three leads were found to have migrated.Patient denied any trauma or falls.The drg system was explanted and replaced with an scs system.No complications were noted during the procedure and postoperatively, the patient is reportedly receiving effective therapy.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
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Event Description
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Related manufacturer reference number 1627487-2021-00288 and 1627487-2021-00289.
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Search Alerts/Recalls
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