ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
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Model Number 3186 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.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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Related manufacturer reference number: 3006705815-2021-05257.It was reported that the patient was unable to put their system into mri mode.Diagnostics revealed high impedances on all contacts of one lead.Imaging showed a lead fracture on the same lead.Surgical intervention may take place at a later date to address the issue.It is unknown which lead is fractured, therefore both leads are being reported.
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Search Alerts/Recalls
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