Model Number SC-1110-02 |
Device Problems
Failure to Charge (1085); High impedance (1291); Telemetry Discrepancy (1629)
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Patient Problems
Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: model#: sc-8216-70 serial #: (b)(4) description: artisan surgical lead, 70cm.
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Event Description
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A report was received that the patient was not able to charge the ipg and lead was showing high impedance reading.It was noted that the patient was having inadequate stimulation and the patient¿s remote control (rc) kept saying communication failed.The patient will undergo a lead and ipg replacement procedure.Device malfunction was suspected on the ipg.
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Manufacturer Narrative
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Additional information was received that no further course of action will be taken at this time.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices 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 was not able to charge the ipg and lead was showing high impedance reading.It was noted that the patient was having inadequate stimulation and the patient¿s remote control (rc) kept saying communication failed.The patient will undergo a lead and ipg replacement procedure.Device malfunction was suspected on the ipg.
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Search Alerts/Recalls
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