MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNKNOWN CODMAN HAKIM VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number UNK HAKIM VALVE

Device Problem Insufficient Information (3190)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 01/09/2018

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon receipt of new relevant information or completion of the investigation, a follow-up report will be submitted.

Event Description

In the literature article ¿cochlear implantation in the presence of a programmable ventriculoperitoneal shunt¿ by richard mark wiet and hussam k.El-kashlan, published otology & neurotology 30:704y707 2009, otology & neurotology, inc., it was reported that after implantation of a hakim programmable valve this infant developed profound hearing loss.Per the article: ¿programmable shunt valves are externally adjustable pressure differential shunts.They are activated and adjusted through the percutaneous application of a specific magnetic signal provided by an external programming device.Consequently, magnetic fields can potentially alter the pressure setting of these programmable shunt valves, causing overdrainage or underdrainage and serious consequences.Cochlear implant internal magnets and/or the external transmitting coil magnets (tcms) can potentially affect the functionality of programmable shunt valves and thus present a management dilemma.The index patient was diagnosed with pneumococcal meningitis at 6 months of age.She developed hydrocephalus and received a ventriculoperitoneal shunt (vps) with a codman hakim programmable valve (chpv).Hearing loss was suspected by parents, and profound sensorineural hearing loss was confirmed with auditory brainstem response testing.Bilateral cochlear implant (ci) placement was recommended to maintain this infant¿s linguistic development in the face of possible impending cochlear ossification.¿ at the time of complaint entry, no device specific information, i.E.Catalogue/lot number, is available.This article is from an fda submission.

Manufacturer Narrative

Corrected fields : device available for evaluation.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: UNKNOWN CODMAN HAKIM VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 7822197
• MDR Text Key: 118438414
• Report Number: 1226348-2018-10617
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HAKIM VALVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1