Model Number 977A260 |
Device Problems
Break (1069); Difficult to Insert (1316); Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/07/2017 |
Event Type
malfunction
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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 healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins) via a manufacturer representative.It was reported that while placing the lead, the lead appeared to be hung up on the tip of the needle.It appeared that the lead was stuck in the needle and would not advance or retract.Once the lead was removed from the needle with some effort, there was slight tear in the silicone coating on the lead between some of the contacts.A new lead was opened and used instead.There was no patient involvement and no symptoms or complications were reported.
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Manufacturer Narrative
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Analysis results were not available as of the date of this report.A follow-up will be submitted when analysis is complete.(b)(4).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 a manufacturer representative.The representative reported that the device was shipped back for analysis.No symptoms or complications were reported.
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Manufacturer Narrative
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Analysis of the electrical lead found that the outer insulation was cut.If information is provided in the future, a supplemental report will be issued.
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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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Search Alerts/Recalls
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