MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S. A. CHPV; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546)

Patient Problems Infarction, Cerebral (1771); Headache (1880); Hematoma (1884); Meningitis (2389)

Event Date 04/29/2015

Event Type  Injury  

Manufacturer Narrative

It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

The literature article "lumboperitoneal shunt surgery for idiopathic normal pressure hydrocephalus (sinphoni-2): an open label randomized trial" published http://dx.Doi.Org/10.1016/s1474-4422(15)00046-0, www.Thelacet.Com/neurology vol 14, june 2015, states that in the post procedure follow-up visits for this study there were a total of 65 adverse events and product malfunctions reported, involving 61 patients.At the three month follow up, there were 2 subdural hematomas with intervention, 4 shunt tube migrations with revision, and 1 shunt tube rupture with revision reported as serious adverse events and 10 postural headaches, 2 asymptomatic subdural effusions, and 2 subdural hematoma without intervention reported as non-serious adverse events.This was a total of 21 events in 19 unspecified patients at the three month follow-up.It was also reported that at the 12 month follow - up there were 3 subdural hematomas requiring intervention, 5 shunt tube migration requiring revision, 1 shunt tube rupture requiring revision, 1 case of meningitis, and 6 cerebral infarctions reported as serious adverse events.There were also 21 postural headaches, 5 asymptomatic subdural effusions, and 2 subdural hematomas without intervention reported as non-serious adverse events.This was 44 events in 42 patients at the 12 month follow-up.The aim of this trial was to determine the safety and efficacy of the lumboperitoneal shunt surgery for normal pressure hydrocephalus.Between march 1, 2010 and oct 19, 2011, 93 patients were enrolled and assigned to treatment groups.Treatment groups were divided by time from diagnosis to treatment.Funding was provided by j&j and nihon medi-physics.Codman hakim programmable valves were used in all patients.There was no patient specific information reported.It was further reported that for the postural headaches and subdural hematomas the patients were treated with adjustments to the pressure settings of the hakim valve.At the time of the complaint entry, the complaint devices were not available for analysis and no sterile lot numbers were reported.

• Brand Name: CHPV
• 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: 5113988
• MDR Text Key: 27145480
• Report Number: 1226348-2015-10560
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Other

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• 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: 09/08/2015
• 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