BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number SC-1110-02 |
Device Problems
Unexpected Therapeutic Results (1631); Charging Problem (2892)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 06/22/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient was no longer able to charge the implantable pulse generator (ipg), and the device was not helping her pain any longer.The patient underwent an ipg replacement procedure.During the procedure, one of the leads could not get connected to the ipg as the lead was corroded.The patient had good coverage on one side post-operatively, however will most likely undergo a revision procedure at a later date due to the one-sided coverage.The explanted ipg will not be returned due to hospital policy.
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: product family: scs-linear leads: upn: m365sc2218700.Model: sc-2218-70.Serial: (b)(4).Batch: 257240.
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Event Description
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It was reported that the patient was no longer able to charge the implantable pulse generator (ipg), and the device was not helping her pain any longer.The patient underwent an ipg replacement procedure.During the procedure, one of the leads could not get connected to the ipg as the lead was corroded.The patient had good coverage on one side post-operatively, however will most likely undergo a revision procedure at a later date due to the one-sided coverage.The explanted ipg will not be returned due to hospital policy.Additional information was received that there will be no further course of action.
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Search Alerts/Recalls
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