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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HOLTER RICKHAM VENTRICULOSTOMY RESERVOIR SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. HOLTER RICKHAM VENTRICULOSTOMY RESERVOIR SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-1616
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Host-Tissue Reaction (1297); Neurological Deficit/Dysfunction (1982); Patient Problem/Medical Problem (2688)
Event Date 01/30/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Complaint sample was not returned to codman and incorrect lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed. The cause(s) of the difficulty reported by the customer could not be determined. If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
 
Event Description
It was reported that after injection of methotrexate, a patient had 2 convulsion crisises with neurological deficits. There was an adverse tissue reaction, cessation of treatment and the edema along the catheter and rickham reservoir with confirmation of extravasation (orifice moved at the parenchyma level). The usage of the reservoir was ceased and treatment for the edema and convulsive crisis underwent neurologic and radiologic surveillance. The device not available for evaluations as it is still in the patient.
 
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Brand NameHOLTER RICKHAM VENTRICULOSTOMY RESERVOIR
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 Key8364124
MDR Text Key136977539
Report Number1226348-2019-10124
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number82-1616
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 Received02/04/2019
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: 02/22/2019 Patient Sequence Number: 1
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