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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE CHPV

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INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE CHPV Back to Search Results
Catalog Number XXX-HAKIM PROGRAMMABLE VALVE
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Headache (1880)
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported on (b)(6), 2020 a stator dislodgement issue with a shunt valve. A hakim programmable shunt was implanted in a patient when the patient was 3 months old in 2008 (exact date not available). The shunt was most recently reprogrammed in 2013, at that time an x-ray demonstrated the set pressure settings along with the radio-opaque marker for identification/reading. On (b)(6), 2020, the patient presented for follow-up evaluation with complaints of early morning headaches and the parents reporting the patient ¿sunset sign in the mornings ¿and clinically had a partial up gaze paresis. The neurosurgeon had not evaluated this patient for the last 7 years in follow-up and could not comment if this paresis was a permanent residual deficit. An x-ray was ordered to identify the current pressure settings and to inform any further actions. Reportedly the x-ray of the valve appeared ¿differently from how a typical codman hakim programmable valve x-ray appears. ¿ there was no radio-opaque dot on the right-hand side and the pressure setting notch was not as expected. No further information was available.
 
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Brand NameHAKIM PROGRAMMABLE VALVE
Type of DeviceCHPV
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 08540
6099362319
MDR Report Key11181128
MDR Text Key230333058
Report Number3013886523-2021-00024
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-HAKIM PROGRAMMABLE VALVE
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 Received01/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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