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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS W/SA 20 A.CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS W/SA 20 A.CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV434-T
Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Patient Problem/Medical Problem (2688); Hydrocephalus (3272)
Event Type  Injury  
Manufacturer Narrative
Visual inspection: a visual inspection based on the pictures shows clear traces of deposits in the reservoir. Further statements cannot be available without a submitted product. Permeability test: not practicable, because the product is not available. Adjustment test: not practicable, because the product is not available. Braking force and brake function test: not practicable, because the product is not available. Results: first, we would like to draw your attention to the fact that an investigation without a product is not possible and therefore not meaningful. In the treatment of hydrocephalus with shunts, the following complications may arise (as described in the literature)1: infections, blockages caused by protein and/or blood in the cerebrospinal fluid, over/under drainage or in very rare cases noise development. We assume that the deposits in the reservoir have led to the said blockage. Whether the progav and the shunt assistant are also affected by a blockage, cannot be determined without the product. What has actually led to infection/ blockage does not explain us, as this would require an investigation of the product. We can exclude a defect at the time of release. The shunt system met all specifications of the final inspection when released from (b)(4).
 
Event Description
It was reported that on (b)(6) 2018, the patient underwent extra ventricular drainage for spontaneous intracerebral hemorrhage, and recovered smoothly. On (b)(6) 2019, the patient developed symptoms of retardation. A head ct showed hydrocephalus. A ventriculoperitoneal (vp) shunt was performed on (b)(6) 2019. The abdominal end was placed on the hepatic septum by laparoscopy, and the shunt valve was placed above the mastoid process. After repeated ct examination, the symptoms of hydrocephalus were not relieved significantly. Repeated pressing of the reservoir sac during the period was smooth. On (b)(6) 2019, it was found that the pressure elasticity of the shunt valve became worse, the patient's headache worsened, and the lumbar puncture test indicated the occurrence of infection. The ventriculoperitoneal (vp) shunt was removed on (b)(6) 2019. Floccules were found in the shunt, resulting in obstruction. The product has been taken out and discarded by the hospital, so there is no sample return.
 
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Brand NamePROGAV SYS W/SA 20 A.CONTROL RESERVOIR
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam d, 14469
GM 14469
Manufacturer Contact
joerg knebel
2 ulanenweg
potsdam d, 14469
GM   14469
MDR Report Key9145720
MDR Text Key165627462
Report Number3004721439-2019-00254
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K161853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV434-T
Device Catalogue NumberFV434-T
Device Lot Number20040618
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/02/2019 Patient Sequence Number: 1
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