Model Number SC-8336-50 |
Device Problems
Fracture (1260); Unexpected Therapeutic Results (1631); Device Dislodged or Dislocated (2923)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Approximated based on the date the manufacturer became aware of the event.
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Event Description
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It was reported that the patient was experiencing loss of stimulation despite reprogramming attempt.Fluro images were taken and revealed that the patients paddle lead was fractured and the middle set of contacts were off to the right.
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Event Description
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It was reported that the patient was experiencing loss of stimulation despite reprogramming attempt.Fluro images were taken and revealed that the patients paddle lead was fractured and the middle set of contacts were off to the right.Additional information was received that the patient underwent a lead replacement procedure.The patient was doing well postoperatively.The explanted lead will not be returned.
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Search Alerts/Recalls
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