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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM HAKIM PROGRAMMABLE VALVE CHPV

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RAYNHAM HAKIM PROGRAMMABLE VALVE CHPV Back to Search Results
Catalog Number XXX-HAKIM PROGRAMMABLE VALVE
Device Problem Separation Problem (4043)
Patient Problem Injury (2348)
Event Date 12/09/2020
Event Type  Injury  
Manufacturer Narrative
The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A physician reported that codman hakim programmable valve was implanted to patient in (b)(6) 8 years ago at (b)(6) years old. After the patient had 3t mri performed, and the valve was x-rayed post mri, the valve cam inside appeared to separate from the housing. Due to this malfunction, the patient underwent revision surgery on (b)(6) 2020. No patient consequence has been reported.
 
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Brand NameHAKIM PROGRAMMABLE VALVE
Type of DeviceCHPV
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
RAYNHAM
325 paramount drive
raynham MA 02767
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 08540
6099362319
MDR Report Key11097414
MDR Text Key224528718
Report Number3014334038-2020-00129
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
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 Received01/19/2021
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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