Model Number 37714 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 05/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient did not charge the battery resulting in an overdischarged ins.The patient also mentioned having poor coverage results, but overall felt she had benefit compared to not using the system.The patient wanted a new battery and talked with a healthcare provider (hcp) about a new battery.Surgical intervention was planned, but not yet scheduled.No further complications were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the patient.It was reported that the patient's ins is scheduled to be replaced on (b)(6) 2018.No further complications are anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from a manufacturer representative (rep) via the patient on (b)(6) 2018.The patient reported having to charge their battery 9-10 hours per recharge session several times a week.The battery was discharged so it was replaced with a new implantable neurostimulator (ins).The cause of the issue was due to patient compliance.The battery was discarded by the customer so it would not be returned for analysis.The issue was resolved and the patient was noted to be alive with no injury.No further complications were reported/are anticipated.
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Manufacturer Narrative
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Corrected information.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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