MAUDE Adverse Event Report: UNK HAKIM PROGRAMMABLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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

Patient Problem Erosion (1750)

Event Date 01/12/2007

Event Type  Injury  

Manufacturer Narrative

Udi: unknown product code.Complaint sample was not returned to codman and no 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.At the present time this complaint is closed.Device not available.

Event Description

In the literature article ¿laparoscopic peritoneal catheter placement: results of a new method in 111 patients.¿ published neurosurgery 61:ons-167¿ons-174, 2007 doi:10.1227/01.Neu.0000279990.80706.1f, it was reported that this (b)(6) female patient presented with nph (normal pressure hydrocephalus), and an unknown hakim programmable valve was implanted for treatment.Post implantation there was wound break down and the surgical site was revised although the device was not removed or replaced.Per the article: ¿although cerebrospinal fluid shunting remains one of the most common neurosurgical procedures, it is fraught with high infection, blockage, and reoperation rates.It has been estimated that the economic cost of ventriculoperitoneal shunting exceeds $1 billion annually.A new laparoscopic technique that eliminates abdominal incisions overlying shunt hardware was applied to 111 patients requiring ventriculoperitoneal shunts in an effort to decrease the morbidity associated with shunting¿one hundred eleven patients underwent 113 laparoscopic ventriculoperitoneal shunt surgeries between february 2003 and december 2004.The average follow up period was 21.7 months (range, 12¿34 mo).Nearly half of the patients (49%) were discharged the next morning and the majority (81%) was discharged within 2 days of surgery.Overall, 15 patients experienced complications requiring reoperation (13.5%) with a 1-year shunt survival rate of 91%.One patient (0.9%) acquired a new shunt infection, whereas two patients (1.8%) developed recurrence from a previous shunt infection.There were no abdominal incision-related complications¿this simplified laparoscopic shunt placement technique, which requires no overlying abdominal incisions, can be performed quickly with high shunt survivability and low infection rates.Furthermore, the laparoscopic method has the advantage of fast recovery time, elimination of preperitoneal or misplaced catheters, and decreased abdominal incision morbidity.The procedure can be performed by either a multidisciplinary team or entirely by neurosurgeons¿.All patients had codman programmable valve systems placed with codman bactiseal silicone ventricular and distal catheters (codman, raynham, ma).Patients with nph had valves set at 140 mmhg, whereas others had varied valve pressure settings depending on their diagnosis or valve pressure history.¿ at the time of complaint entry there is no catalogue or lot number information available.This submission is related to a literature article discovered in an effort to support the cer submission process, as such, the associated time frame of event dates includes but is not limited to 20 years.

• Brand Name: UNK HAKIM PROGRAMMABLE VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 7099491
• MDR Text Key: 94284880
• Report Number: 1226348-2017-10942
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 59 YR