ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD
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Model Number 3186 |
Device Problem
Low impedance (2285)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.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.During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.
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Event Description
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Related manufacturer report number 1627487-2021-15417, 3006705815-2021-03308.It was reported that the patient's system would not go into mri mode due to low impedance issues.Reportedly, patient needed mri for an unrelated surgery.As a result, a surgical intervention occured wherein the system was explanted to address the issue.
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Search Alerts/Recalls
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