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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG BURR RESERVOIR SET PED HYDROCEPHALUS MANAGEMENT

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CHRISTOPH MIETHKE GMBH & CO KG BURR RESERVOIR SET PED HYDROCEPHALUS MANAGEMENT Back to Search Results
Model Number FV041T
Device Problem Mechanical Problem (1384)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 06/29/2020
Event Type  Injury  
Manufacturer Narrative
Result: an investigation was not possible because no product was send for investigation. As described in our instructions for use, in the treatment of hydrocephalus with shunts, the following complications may arise (as described in scientific literature): infections, blockages caused by protein and/or blood in the cerebrospinal fluid or over-/ and under-drainage. Due to violent shocks from the outside (accident, fall, etc. ) the integrity of the shunt may be endangered. However, we cannot finally clarify what influenced the product condition, as this would require an examination of the reservoir. Based on our documentation however we can exclude a defect at the time of release. The burrhole reservoir met all specifications of the final inspection when released from christoph miethke (b)(4).
 
Event Description
It was reported that there was a problem with a burr reservoir set ped. In (b)(6) 2015. The product was used for surgery for postmeningitis hydrocephalus in a (b)(6)-old newborn. The patient was discharged because of good progress. (b)(6) 2020 : emergency hospitalization due to sudden changes in condition (headache and vomiting). Shunt failure was not seen on ct images. There was a sign of slit ventricle syndrome, so the setting pressure was changed from 5 cm h2o to 10 cm h2o. (check the changes on the computer, no x-ray). Since there was no improvement after that, a surgeon tried to change the pressure to 15cm h2o on (b)(6), but he could not change the pressure after trying to change it several times. Certas was performed on (b)(6). At last, the patient's conditions improved. After removing the valve, the surgeon tried to change the pressure, but could not confirm the change on the compass. No infection. The reporter suspected a malfunction. Patient information: age: 5 years. Weight: unknown. Hight: unknown. Gender: unknown. Associated mdr#: 3004721439-2020-00162, 3004721439-2020-00163, it's the same patient.
 
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Brand NameBURR RESERVOIR SET PED
Type of DeviceHYDROCEPHALUS MANAGEMENT
Manufacturer (Section D)
CHRISTOPH MIETHKE GMBH & CO KG
ulanenweg 2
potsdam, 14469
GM 14469
Manufacturer (Section G)
CHRISTOPH MIETHKE GMBH & CO KG
ulanenweg 2
potsdam, 14469
GM 14469
Manufacturer Contact
joerg knebel
ulanenweg 2
potsdam, 14469
GM   14469
MDR Report Key10393062
MDR Text Key202535374
Report Number3004721439-2020-00161
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K011030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFV041T
Device Catalogue NumberFV041T
Device Lot NumberUNKNOWN
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 Received07/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/11/2020 Patient Sequence Number: 1
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