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

Catalog Number 82-3100

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 08/18/2017

Event Type  Injury  

Manufacturer Narrative

Udi: product made prior to compliance date, gtin unavailable.Upon completion of the investigation, a follow up report will be filed.

Event Description

The clinician reported that the valve was damaged, the motor was releasing (detached).The valve was removed from the patient on (b)(6) 2017.Patient: (b)(6) years old.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).The valve was returned for evaluation.Visual inspection of the valve found that the stator, x-ray dot and pivot were dislodged.Due to this, the programming and pressure tests could not be performed.The valve was leak, flush and reflux tested, with no issues found.The valve was then dismantled and evaluated at appropriate magnification.The casing was broken and bump marks were noted in the valve casing.This is likely due to the valve receiving a hard knock.Corrosion was found on the stator.The lot history record for product was reviewed for completeness during the release process to inventory.No issues were found when the device was released to stock.Investigation of the returned device confirmed the issue reported by the customer.The root cause of the corrosion could not be clearly determined.While root cause could not be conclusively determined, it is likely that the dislodged stator and corrosion was due to the valve receiving a hard knock.Stator dislodgement of chpv was investigated through a previous investigation.The investigation concluded that several factors may contribute to the stator dislodgement.Trauma to the valve, whether it occurs while implanted or at explant, was the root cause of stator dislodgement.Galvanic corrosion could not be established as a direct root cause for those valves investigated, however it was found to be a contributing factor when trauma to the valve was found.Corrosion, when it arises, only arises after long term exposure to csf.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
• 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
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6849275
• MDR Text Key: 85153494
• Report Number: 1226348-2017-10667
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974739
• 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: Initial,Followup,Followup

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: 82-3100
• Device Lot Number: PD2543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 09/20/2017; 11/17/2017
• Supplement Dates FDA Received: 09/22/2017; 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/1996
• 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