MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3832

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device 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 patient is male (b)(6), accepted v-p shunt with 823832 and 823072 on (b)(6) 2016.No other anomalies were occurred.At the beginning of (b)(6) the patient returned hospital and it was noted that the ventricle enlarged from ct report.The surgeon tried several times to adjust pressure but symptom didn't change better.On (b)(6) 2016 the surgeon did revision surgery and implant new catheter in another side of ventricle.The original catheter was not removed because of wound.Now the patient condition is stable.The sample can't be returned.

• Brand Name: PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29 case postale; le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6218687
• MDR Text Key: 63741833
• Report Number: 1226348-2017-10008
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K992173
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-3832
• Device Lot Number: CRNBH6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• 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
• Treatment: 82-3072
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR