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

Catalog Number 82-3101

Device Problems Occlusion Within Device (1423); Device Issue (2379)

Patient Problem Headache (1880)

Event Date 09/03/2015

Event Type  Injury  

Manufacturer Narrative

Gtin: not available.Upon completion of the investigation a follow up report will be filed.

Event Description

On (b)(6) 1997, the device was originally implanted via v-p shunt to a patient with nph after sah ((b)(6) female).The initial setting pressure was 70mmh2o.Sometime after implantation, the patient had a headache and ventricular enlargement was noted, so the setting pressure was lowered to 40mmh2o.On v 2009, the patient had a headache and ventricular reduction was noted.The setting pressure was changed to 60mmh2o.On (b)(6) 2015, the patient had a headache and ventricular enlargement was noted again.The surgeon confirmed through images that the valve and the distal catheter were occluded, and removed both of them.The device was replaced with the same new device at 60mmh2o.The patient's condition is good after the revision.It was also reported that the white marker could not be found inside the valve and the surgeon requests to clarify the root cause of this incident.

Manufacturer Narrative

Upon completion of the investigation it was noted that the valve was received with the valve casing outside the silicone housing.The silicone housing was torn/cut this has probably happened during ex-plantation.The stator and the x ray dot were dislodged.The x ray dot was found on the cam mechanism magnets.Therefore; the cam position/pressure could not be determined.The valve was dismantled and was examined under microscope at appropriate magnification: no damage to the valve casing was noted.Review of the history device records confirmed the valve product code 82-3100, with lot pf2906, conformed to the specifications when released to stock in 1997.The root cause(s) of the dislodgement could not be determined.However, this valve was manufactured prior to enhancements introduced to the stator stamping tool during 2004/2005 that will minimize this type of dislodgement.The root cause to the tear/cut in the silicone housing could be due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu silicone has a low cut/tear resistance, this however could not be determined.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE WIHOUT PRECHAMBER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5101988
• MDR Text Key: 26715959
• Report Number: 1226348-2015-10555
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2002
• Device Catalogue Number: 82-3101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/1997
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR