MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VALVE INLINE UNIT (INTEGRAL CON); SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3844

Device Problem Programming Issue (3014)

Patient Problems Death (1802); Neurological Deficit/Dysfunction (1982); No Information (3190)

Event Type  Death  

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Event Description

As reported by the ous sales rep, chpv inline valves w/o siphonguard changed their setting after patients left the hospital.There were no reports of delay or patient harm.

Manufacturer Narrative

Updated information : additional event information has been provided by the initial reporter.It has been reported that the patient died subsequent to the initially reported issue.No cause of death or other medical records have been provided.To date, the device has not been returned for evaluation.If additional relevant information becomes available, the complaint will be reopened and a follow-up report will be submitted.At present, we consider this complaint to be closed.

Event Description

As reported by the ous sales rep, chpv inline valve had unexpected setting changes after implantation, the patient developed subdural hematoma with symptoms of syncope and subsequently died.It was reported that the patient condition had improved, ambulating with a walker, therefore, the valve programming was changed from 110 mmhg to 100 mmhg, although there was no x-ray confirmation of setting change.Thirteen days after the programming change, the patient presented to the hospital, with syncope, and was diagnosed with subdural hematoma.The valve setting was noted to be at 30 mmhg at this time.The patient subsequently died the following day, and the valve was removed post mortem.No magnetic field exposure or trauma to valve was reported.

Manufacturer Narrative

Additional information has been received indicating that the patient experienced neurological deficits related to the event.It was also reported that the device would not be available for evaluation.Upon review of manufacturing records, a follow-up report will be submitted.

Manufacturer Narrative

Updated udi : (b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies related to the reported issue.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information 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: HAKIM VALVE INLINE UNIT (INTEGRAL CON)
• 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: 7292343
• MDR Text Key: 100933954
• Report Number: 1226348-2018-10178
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 82-3844
• Device Lot Number: 133046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death