Model Number SC-1110-02 |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problems
Pain (1994); Discomfort (2330); Inadequate Pain Relief (2388)
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Event Date 04/27/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient's spinal cord stimulator system was explanted due to the ipg causing pocket site pain as well as the system not helping the patient's pre-existing pain.The patient has reportedly fully recovered following the explant procedure.
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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: unknown, model: unknown, serial: unknown, batch: unknown.The explanted lead was discarded and will not be returned to bsc for analysis.
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Manufacturer Narrative
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The explanted ipg was returned and analyzed.The reported complaint of pocket site pain could not be investigated due to significant damage to the ipg.A hole was found in the ipg case and a corroded pcba was found.A review of the ipg profile showed that the device had been working normally prior to the explant procedure.The damage to the ipg was considered to occur during the explant procedure and is not related to the reported complaint of pocket site pain.A review of the instructions for use found that pocket pain is a known inherent risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation.Therefore, the most probable cause is known inherent risk of device use.
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Event Description
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It was reported that a patient's spinal cord stimulator system was explanted due to the ipg causing pocket site pain as well as the system not helping the patient's pre-existing pain.The patient has reportedly fully recovered following the explant procedure.
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Search Alerts/Recalls
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