Catalog Number XXX-HAKIM PROGRAMMABLE VALVE |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Convulsion/Seizure (4406)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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10 of 10 reports.Other mfg report numbers: 3013886523-2021-00480, 3013886523-2021-00481, 3013886523-2021-00482, 3013886523-2021-00483, 3013886523-2021-00484, 3013886523-2021-00485, 3013886523-2021-00486, 3013886523-2021-00487, and 3013886523-2021-00488.Child's nervous system (2020) published: "programmable valve breakage in shunt systems of children with posthemorrhagic hydrocephalus after minor head trauma¿a case series" purpose: "we report five rare cases of programmable valve breakage (codman hakim-medos valve) in shunt systems of children with posthemorrhagic hydrocephalus.Only four similar studies have been published in the current literature." methods: "between 2013 and 2018, five children with posthemorrhagic hydrocephalus were admitted to the pediatric department.All patients had a history of slight blows to the head in a minor trauma and follow up mri scans.After initial clinical examination, cranial computed tomography (ct) and x-ray were conducted." results: "in all cases, pumping the reservoir resulted in very slow refilling.The cranial ct in one patient showed slit ventricles confirming the suspicion of overdrainage, the other cases a slight enhancement of the hydrocephalus.In lateral x-rays of the skull in comparison to the first x-ray control of the shunt valve, the pressure control chamber could be seen dislocated in the inferior part of the reservoir in all cases.Surgery revealed that the shunt valve was broken.The pressure control chamber had dropped to the bottom of the reservoir.After implantation of a new shunt valve, the symptoms resolved completely in all five children.Overall this complication occurred in 4.3% (5 of 85 implanted codman hakim-medos valve) of all children necessitating ventriculoperitoneal shunt implantation between january 2013 and december 2018." conclusion: "the well-accepted codman hakim-medos programmable valve is part of a tube-system, which is designed to offer the possibility of a reliable and precise treatment of hydrocephalus.Various mechanical and non-mechanical complications of shunt systems have been reported.Valve breakage is a very rare condition, often missed, and must be kept in mind when trauma and prior mri scan are reported." patient 5 - malfunction - pressure control chamber dislocated case report: a (b)(6) boy with a history of shunt placement for malresorptive hydrocephalus after posthemorrhagic hydrocephalus with infantile cerebral palsy was admitted for the annual mri routine check.Secondary generalized seizures with probably minor head traumas appeared 3 times in the last months.There was no history of vomiting, headache, dizziness, and further neurologic deterioration.The cranial magnetic resonance imaging (mri) showed in comparison to previous images no hydrocephalus or overdrainage.Thereafter, the shunt valve could not be resetted routinely.A lateral skull x-ray was performed to rule out spontaneous resetting of the valve induced by an external magnetic field.The initial valve-opening pressure was adjusted to 140 mmh2o.The actual x-ray showed a resetted valve- opening pressure to 100mmh2o.Further, the pressure control chamber could be seen dislocated in the inferior part of the reservoir.After implantation of a new shunt valve (codman hakim-medos valve), the boy could be discharged after 7 days without any complications.Generalized seizures did not appear in the further follow up.Postoperative x-ray control showed the new valve with the pressure control chamber in correct position.Https://doi.Org/10.1007/s00381-020-04541-6.
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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10 of 10 reports.Other mfg report numbers: 3013886523-2021-00480, 3013886523-2021-00481, 3013886523-2021-00482, 3013886523-2021-00483, 3013886523-2021-00484, 3013886523-2021-00485, 3013886523-2021-00486, 3013886523-2021-00487, and 3013886523-2021-00488.Child's nervous system (2020) published: "programmable valve breakage in shunt systems of children with posthemorrhagic hydrocephalus after minor head trauma¿a case series" purpose: "we report five rare cases of programmable valve breakage (codman hakim-medos valve) in shunt systems of children with posthemorrhagic hydrocephalus.Only four similar studies have been published in the current literature." methods: "between 2013 and 2018, five children with posthemorrhagic hydrocephalus were admitted to the pediatric department.All patients had a history of slight blows to the head in a minor trauma and follow up mri scans.After initial clinical examination, cranial computed tomography (ct) and x-ray were conducted." results: "in all cases, pumping the reservoir resulted in very slow refilling.The cranial ct in one patient showed slit ventricles confirming the suspicion of overdrainage, the other cases a slight enhancement of the hydrocephalus.In lateral x-rays of the skull in comparison to the first x-ray control of the shunt valve, the pressure control chamber could be seen dislocated in the inferior part of the reservoir in all cases.Surgery revealed that the shunt valve was broken.The pressure control chamber had dropped to the bottom of the reservoir.After implantation of a new shunt valve, the symptoms resolved completely in all five children.Overall this complication occurred in 4.3% (5 of 85 implanted codman hakim-medos valve) of all children necessitating ventriculoperitoneal shunt implantation between january 2013 and december 2018." conclusion: "the well-accepted codman hakim-medos programmable valve is part of a tube-system, which is designed to offer the possibility of a reliable and precise treatment of hydrocephalus.Various mechanical and non-mechanical complications of shunt systems have been reported.Valve breakage is a very rare condition, often missed, and must be kept in mind when trauma and prior mri scan are reported." patient 5 - malfunction - pressure control chamber dislocated case report: a (b)(6) boy with a history of shunt placement for malresorptive hydrocephalus after posthemorrhagic hydrocephalus with infantile cerebral palsy was admitted for the annual mri routine check.Secondary generalized seizures with probably minor head traumas appeared 3 times in the last months.There was no history of vomiting, headache, dizziness, and further neurologic deterioration.The cranial magnetic resonance imaging (mri) showed in comparison to previous images no hydrocephalus or overdrainage.Thereafter, the shunt valve could not be reset routinely.A lateral skull x-ray was performed to rule out spontaneous resetting of the valve induced by an external magnetic field.The initial valve-opening pressure was adjusted to 140 mmh2o.The actual x-ray showed a reset valve- opening pressure to 100mmh2o.Further, the pressure control chamber could be seen dislocated in the inferior part of the reservoir.After implantation of a new shunt valve (codman hakim-medos valve), the boy could be discharged after 7 days without any complications.Generalized seizures did not appear in the further follow up.Postoperative x-ray control showed the new valve with the pressure control chamber in correct position.Https://doi.Org/10.1007/s00381-020-04541-6.
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Event Description
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N/a.
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Manufacturer Narrative
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The hakim valve was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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Search Alerts/Recalls
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