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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH PED.PRECHAMBER HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH PED.PRECHAMBER HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FX466T
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Fatigue (1849); Headache (1880)
Event Date 04/11/2020
Event Type  Injury  
Manufacturer Narrative
If further information becomes available, a follow-up will be submitted.
 
Event Description
It was reported that there was an issue with the progav shunt system, as per information received via mw 5094328. In 2019, the progav 2. 0 valve was implanted and set at 17 with general instructions to have the shunt inspected after an magnetic resonance imaging (mri) due to potential for the magnet to change the valve setting. On (b)(6) 2020 the patient received a pair of headphones with "intuitive touch control". Basic functions were controlled by swiping or touching the surface area on the right ear cup. The patient wanted to experience the touch control and tried the new headphones for about 10 minutes. Twenty minutes later, she developed an acute headache and fatigue that were signs consistent with a shunt malfunction or failure symptoms. The patient was hospitalized with ventricular decompensation due to over drainage without shunt malfunction. Further details have been requested.
 
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Brand NamePROGAV 2.0 WITH PED.PRECHAMBER
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO. KG
2 ulanenweg
potsdam, 14469
GM 14469
MDR Report Key10097220
MDR Text Key192637607
Report Number2916714-2020-00166
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 05/04/2020,07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX466T
Device Catalogue NumberFX466T
Device Lot Number20034661
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Report Sent to FDA05/04/2020
Distributor Facility Aware Date07/31/2020
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/28/2020 Patient Sequence Number: 1
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