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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.

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CODMAN & SHURTLEFF, INC. Back to Search Results
Catalog Number UNK HAKIM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); Tissue Damage (2104)
Event Date 04/15/2018
Event Type  Injury  
Manufacturer Narrative
Udi: unknown part number, attempts to obtain product were unsuccessful, udi unavailable. Complaint sample was not returned to codman and no 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 additional relevant information becomes available in the future, 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. This event was reported via a literature article. Refer to mdrs 1226348-2018-10848, 1226348-2018-10849, 1226348-2018-10851 for information regarding the additional events.
Event Description
In the literature article ¿analysis of codman microcerebrospinal fluid shunt¿ by axel sandvig, kai arnell, jan malm | anders eklund, lars-owe d. Koskinen, published brain and behavior. 2018;8:e01002. Https://doi. Org/10. 1002/brb3. 1002, it was reported that implant of unknown codman hakim adjustable microvalves, 8 unidentified patients had adverse events that required additional intervention and/or treatment. These events included: hygroma, shunt infection, necrosis, pressure wound. Infection and vomiting. Per the article: ¿results: thirty-seven children (19 boys, 18 girls) were identified. Within the first month after shunt placement, a total of 10 patients (27%) developed complications including infections, hygromas, and shunt dysfunction. Shunt survival varied from 1 week to 145 months. Over the 10-year follow-up period, 13 children had their shunts replaced, six of them with a chav without any further complications. A bench test of the cmav was done to test whether the opening pressure was in agreement with the manufacturer¿s specifications. Our results were generally in agreement with specifications stated by the manufacturer. Conclusion: replacing a cmav with a chav was well tolerated by the patients. Bench test results were generally in agreement with manufacturers specifications. Replacing a cmav with a chav in pediatric hydrocephalus patients can be accomplished safely. ¿ table 1 describes the adverse events as: 3 patients with hygroma treated with valve pressure adjustments, 2 patients with shunt infection treated with revision of the device, necrosis of the insertion site treated with revision of the device, 1 patient with pressure wound/infection treated with antibiotics and a single event of vomiting treated with medications. At the time of complaint entry, no device specific information, i. E. Catalogue/lot number, is available. This was discovered via the monthly literature review.
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Brand NameNI
Type of DeviceNI
Manufacturer (Section D)
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
325 paramount drive
raynham MA 02767
Manufacturer Contact
karen anigbo
11 cabot boulevard
mansfield, MA 02048
MDR Report Key8143139
MDR Text Key129650056
Report Number1226348-2018-10850
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HAKIM
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 Received01/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/07/2018 Patient Sequence Number: 1