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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-3100
Device Problem Device Difficult to Program or Calibrate (1496)
Patient Problems Headache (1880); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Neurological Deficit/Dysfunction (1982)
Event Date 12/05/2018
Event Type  Injury  
Manufacturer Narrative
Udi - (b)(4). It has been reported that the device will be returned for evaluation. Upon receipt of the device or additional relevant information, a follow-up report will be submitted.
 
Event Description
It was reported that an initial surgery took place on (b)(6) 2018. On (b)(6) 2019 the patient experienced an inability to adjust the valve after multiple attempts. The valve became fixed to the value of 30mmhg and the patient developed bilateral hygromas and presented intra-cranial hypotension, with mild compression of the brain parenchyma. Multiple attempts were performed in order to adjust the valve albeit with no effect. The problem was aggravated by the fact that the valve, after all these attempts became blocked at the lowest value, as it was confirmed by x-ray. The patient developed a syndrome of intracranial hypotension, with inability to walk and progressively worsening headache. Finally, the valve was replaced (only the valve, the ventricular and peritoneal catheters remained, with gradual alleviation of his symptomatology.
 
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Brand NameHAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
rue girardet 29
le locle CH-24 00
SZ CH-2400
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
rue girardet 29
le locle CH-24 00
SZ CH-2400
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8374835
MDR Text Key137291825
Report Number1226348-2019-10131
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-3100
Device Lot Number211448
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2018
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: 02/27/2019 Patient Sequence Number: 1
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