Model Number 3189 |
Device Problem
Low impedance (2285)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient was unable to set their ipg to mri mode due to low impedances on both leads.It was noted that the patient had a fall prior and impedances would change depending on patient movement.As a result, the patient underwent surgical intervention during which the leads were explanted and replaced.Effective therapy was established post-operatively.
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Manufacturer Narrative
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Date of event is estimated.Initial reporter phone number:(b)(6).
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Manufacturer Narrative
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The allegation of potentially fractured leads was not confirmed.Both leads show normal impedances.Both leads have no visual anomalies in the lead body, stim ends or terminal ends.Setscrew marks were seen on the terminal block electrodes at the terminal end.The two swift lock anchors functioned normally with no anomalies.
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Search Alerts/Recalls
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