MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC.; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number UNK VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

Udi -- unknown part number, all 3 attempts to obtain product were unsuccessful, udi.Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported by biomarin, that this study patient had an unknown rickham device, product number and lot number unknown, implanted and developed an infection that resulted in device revision.After brineura infusion was administered, a cerebrospinal fluid culture was taken and returned positive for staphylococcus epidermidis, confirming a bacterial infection of the patient's rickham device.The patient was subsequently hospitalized.On an unreported date, the patient's icv device was removed.Treatment for the event included vancomycin for 14 days.Approximately 1 month later,  a new device was implanted.No action was taken with brineura due to the event.However, it was reported that treatment with brineura was resumed.The reporter assessed the event of device related infection as related to the unspecified rickham codman icv device/reservoir.The outcome of the event was reported as recovered/resolved on an unreported date.

Manufacturer Narrative

It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no product or 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.

• Brand Name: NI
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8034046
• MDR Text Key: 126067394
• Report Number: 1226348-2018-10795
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

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: No Information
• Device Catalogue Number: UNK VALVE
• Device Lot Number: 144618
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR