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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE N. V. HOUSING-DISTAL U.(SIPH) SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE N. V. HOUSING-DISTAL U.(SIPH) SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number UNK HAKIM
Device Problem Device Difficult to Program or Calibrate (1496)
Patient Problem Failure of Implant (1924)
Event Date 10/03/2018
Event Type  Injury  
Manufacturer Narrative
Udi: unknown part number, attempts to obtain product were unsuccessful, udi unavailable. The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
As reported by the affiliate, after 3 months, a hakim valve could not be reprogrammed and was revised. The product will be returned.
 
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Brand NameHAKIM PROGRAMMABLE N. V. HOUSING-DISTAL U.(SIPH)
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
CODMAN & SHURTLEFF, INC.
325 paramount drive
raynham MA 02767
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
7819715608
MDR Report Key8108307
MDR Text Key128560464
Report Number1226348-2018-10830
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK HAKIM
Device Lot Number164499
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/28/2017
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: 11/27/2018 Patient Sequence Number: 1
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