CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE, RT ANGLE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
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Catalog Number 82-3184 |
Device Problem
Programming Issue (3014)
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Patient Problem
No Information (3190)
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Event Date 11/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.
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Event Description
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It was reported that the physician was unable to change valve settings.Valve was not revised, and patient did not experience symptoms.
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Manufacturer Narrative
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(b)(4).It was not possible to investigate the complaint as no sample was returned for evaluation.Numerous attempts were made to recover the device, with no success.If the sample is returned in the future, this complaint will be re-opened and evaluated.Review of the history device records confirmed the valve product code 82-3184 with lot 116082, conformed to the specifications when released to stock on the 1st february 2017.At the present time this complaint is closed.
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