Model Number 3186 |
Device Problem
Impedance Problem (2950)
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Patient Problems
Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain patient weight, and but it was not received.
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Event Description
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Related manufacturer report number: 3006705815-2021-03976, 3006705815-2021-03975.It was reported the patient was unable to place their scs system into mri mode, prior to an mri procedure.Diagnostics confirmed low impedance on patient's leads.Surgery may occur later to address the issue.
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Manufacturer Narrative
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Correction: section h6: the clinical code should have been 4582 - no clinical signs, symptoms or conditions instead of 2388 - inadequate pain relief reported in the initial report.Correction: section h6: the health impact code should 4610 - inadequate/inappropriate treatment or diagnostic should not have been added to the initial report 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 incident could not be conclusively determined.
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Event Description
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Additional information received indicate the patient underwent a surgical procedure for a lead revision on (b)(6) 2021, wherein the leads were explanted and replaced.Therapy re-established post-operatively.
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Search Alerts/Recalls
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