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

Catalog Number UNK HAKIM

Device Problem Insufficient Information (3190)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

Udi - unknown part number, all 3 attempts to obtain product were unsuccessful, udi unavailable.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 ¿neurological outcome and frequency of overdrainage in normal pressure hydrocephalus directly correlates with implanted ventriculoperitoneal shunt valve type¿ by yavor bozhkov, karl roessler, nirjhar hore, michael buchfelder & sebastian brandner, published neurological research, 39:7, 601-605, doi: 10.1080/01616412.2017.1321300, it was reported that after implantation of an unknown hakim programmable valve, patient # 1 presented with overdrainage with symptoms of headache and subdural hematoma, the device was revised until resolution of the hematoma.Per the article: ¿the correlation between neurological outcome and frequency of overdrainage in the management of idiopathic normal pressure hydrocephalus (inph) using different ventriculoperitoneal shunt valve types is under investigation.Thus, we retrospectively compared one group of inph patients implanted with a programmable differential pressure valve (dpv) with another group treated by implantation of a dpv in combination with a flow-regulated antisiphon device valve (asd)¿ in the dpv-group, three patients experienced severe symptomatic overdrainage as defined by development of subdural hematoma necessitating surgical evacuation.The valve setting at occurrence of subdural hematoma was 180 mmh2o in all three patients.¿ patient 1 presented with onset of headache and a mild right-sided hemiparesis 2 months after shunt placement.The ct scan showed a left-sided chronic subdural hematoma (csdh).The vp shunt was ligated and the hematoma evacuated.Two months after evacuation of the csdh the patient presented with progressive symptoms of inph again.The follow-up ct scan revealed complete resolution of the subdural hematoma.The shunt system was correspondingly re-opened with adjustment of the valve pressure to 140 mmh2o and simultaneous placement of a gravitational unit (shuntassistant sa, miethke) was performed.At the time of complaint entry, no device specific information, i.E.Catalogue/lot number, is available.

• Brand Name: NI
• 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: 8005728
• MDR Text Key: 125032824
• Report Number: 1226348-2018-10748
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2018

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: UNK HAKIM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/25/2018
• 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 Outcome(s): Other