Model Number SC-1110-02 |
Device Problems
Telemetry Discrepancy (1629); Charging Problem (2892)
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Patient Problems
Pain (1994); Burning Sensation (2146)
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Event Date 04/08/2016 |
Event Type
Injury
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Manufacturer Narrative
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Udi= (b)(4).
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Event Description
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A report was received that the patient had pain and some burning sensation around the ipg site.It was noted that the patient's ipg was not holding a charge and it was completely depleted and it will not communicated with the remote control (rc).The patient will undergo replacement.
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Manufacturer Narrative
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Additional information was received that the patient underwent a revision procedure wherein the ipg was replaced.No device malfunction was suspected.The patient was doing well postoperatively.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
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Event Description
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A report was received that the patient had pain and some burning sensation around the ipg site.It was noted that the patient's ipg was not holding a charge and it was completely depleted and it will not communicated with the remote control (rc).The patient will undergo replacement.
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Search Alerts/Recalls
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