ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
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Model Number 3186 |
Device Problems
Low impedance (2285); Impedance Problem (2950)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2018 |
Event Type
Injury
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Event Description
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Related manufacturer reference number: 3006705815-2021-03668, 3006705815-2021-03696.It was reported the patient was experiencing invalid impedances.In turn, the ipg was unable to enter mri mode.Troubleshooting performed but was unsuccessful.Surgical intervention may occur later to address the issue.
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Manufacturer Narrative
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As a result, the patient¿s system was explanted.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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Additional information received indicated that surgical intervention took place on 09aug2021, wherein the patient entire scs system was explanted to address the issue.
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Search Alerts/Recalls
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