MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN PROGRAMMABLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3XXX

Device Problems Mechanical Problem (1384); Migration (4003)

Patient Problems Failure of Implant (1924); Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

Udi -- unknown part number, attempts to obtain product were unsuccessful, udi unavailable.Multiple attempts to obtain additional information were not successful; therefore a full evaluation could not be performed.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.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.

Event Description

In the literature article ¿cervical compressive myelopathy caused by malfunction of a programmable cerebrospinal fluid shunt valve¿ by kota satoa, toru yamashitaa, keichiro tsunodaa, mami takemotoa, nozomi hishikawaa, jinwei shanga, yasuyuki ohtaa, ken kuwaharab, takao yasuharab, isao dateb, koji abea, published https://www.Sciencedirect.Com/science/article/pii/s2214751918300082?via%3dihub, it was reported that after implantation of an unknown chpv, the patient had overdrainage and neurologic "defitics", spinal cord damage, there was unexpected setting change of the valve, catheter migration after implant and device revision.Per the article: ¿a (b)(6) man with a dull headache visited a local neurosurgeon in (b)(6) 1998 and was diagnosed with idiopathic hydrocephalus.In (b)(6) 1998, a vp shunt operation was performed with a codman® hakim® programmable valve system (depuy synthes, raynham, ma, usa) (valve pressure, 160 mm h2o).The valve pressure increased to 180 mm h2o 1 month after surgery because of a persistent dull headache.However, 4 months after surgery, the valve pressure spontaneously changed from 180 to 160 mm h2o; however, he was doing fine.When the patient turned (b)(6), he developed intolerable abdominal pain, and abdominal x-rays revealed twisting of the intraperitoneal tube and reversal of the tip end position toward the head.He underwent abdominal surgery for revision of the distal intraperitoneal shunt tubing replacement, and his abdominal pain disappeared.At the age of (b)(6), the valve pressure spontaneously decreased again from 160 to 130 mm h2o; however, given that he was doing well no shunt setting changes was pursued.At the age of (b)(6), the patient newly developed bilateral tinnitus, bilateral hand numbness, and weakness in the left leg.At another local hospital, he underwent brain computed tomography (ct) that showed slit ventricles compared with the ventricles 2 years before, and without a change in valve pressure.However, the ventricles spontaneously enlarged and recovered again within 1 month.Therefore, he visited our hospital at the age of (b)(6).Upon admission to our hospital, the patient presented slight proximal muscle weakness in the upper and lower extremities (manual muscle test: r4+/l4).Muscle tonus of the left extremities was spastic with hyperreflexia.He had decreased superficial sensations in the left body and extremities.Laboratory data showed no abnormalities, and csf analysis revealed a low opening pressure (70 mm h2o) and an increase in protein (167 mg/dl) with a normal cell count (3/l).Peripheral nerve conduction was normal.Muscle electromyography in the upper extremities revealed chronic neurogenic change.Brain ct showed slightly enlarged lateral and third ventricles.

• Brand Name: CODMAN PROGRAMMABLE VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 7819715608
• MDR Report Key: 8016760
• MDR Text Key: 125385103
• Report Number: 1226348-2018-10772
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-3XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2018
• 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 Age: 46 YR