Model Number MN10450-50A |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2023 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer reference number: 1627487-2024-07901.It was reported that the patient¿s therapy strength was decreasing on its own.Diagnostic revealed high impedance on left lead.Reprogramming was unable to resolve the issue.Reportedly, the left lead was fractured.As such, surgical intervention took place on (b)(6) 2024 wherein the left lead was explanted.When placing the new left lead, the existing right lead migrated.As such, the lead was explanted as well and new leads were implanted to address the issue.New leads were implanted at l1 instead of t12 due to scar issue.Investigation was unable to determine which is the right lead.
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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 incident could not be conclusively determined.
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Event Description
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Additional information received indicates that the lead fracture was confirmed on fluoroscopy.Reportedly, therapy was confirmed post op.
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Manufacturer Narrative
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Corrected data: b2: it was inadvertently reported as "life-threatening" in the initial report.The correct information has been updated in this record.
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Search Alerts/Recalls
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