MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.

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.

Manufacturer Narrative

The previously filed report did not include the outcomes attributed to adverse event.This report has been updated to reflect the corrected information.

• Brand Name: NI
• Type of Device: NI
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8143139
• MDR Text Key: 129650056
• Report Number: 1226348-2018-10850
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HAKIM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 01/22/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention