MEDTRONIC NEUROSURGERY RESERVOIR 44111 VENTRICULAR BURR HOLE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR
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Model Number 44111 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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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It was reported the patient underwent implantation of the reported device on an unreported date.In (b)(6) 2019, the patient initiated treatment with brineura for the indication of neuronal ceroid lipofuscinosis.It was stated that 2 months into treatment, the device became disconnected, and again the patient experienced a repeat disconnection between the reservoir and ventricle tubing 4 months after the first disconnection.As a result, an even smaller reservoir was placed.The reservoir has been maintained since replacement (11 months).No laboratory or diagnostic tests were reported.The reporter did not provide an assessment of the event of device dislocation in relation to treatment with brineura.The reporter assessed the event of device dislocation as related to the icv device.No other etiological factors were reported.
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Search Alerts/Recalls
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