MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE, RT ANGLE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3184

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Event Description

As reported by the ous affiliate, a chpv and a bactiseal catheter did not work after being implanted.There were no reports of delay or patient harm.

Manufacturer Narrative

Updated udi (b)(4).The valve and catheters were returned for evaluation.The position of the cam when valve was received was 40mmh2o.The valve was visually inspected: needle holes in the needle chamber were noted.The valve was tested for programming and passed.The valve was flushed; no occlusions noted.The valve was leak tested and passed.The catheters were irrigated, no occlusions noted.The valve was reflux tested and passed.The valve was then pressure tested and passed.A review of manufacturing records found no discrepancies.Based on evaluation of the products, no device failure has occurred.The devices functioned as intended.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.Refer to mdr 1226348-2018-10102 for information regarding the second device associated with this event.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: HAKIM PROGRAMMABLE VALVE, RT ANGLE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 7237675
• MDR Text Key: 98909707
• Report Number: 1226348-2018-10101
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 82-3184
• Device Lot Number: CVKCPH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Date Manufacturer Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 82-3072; 82-3072
• Patient Outcome(s): Required Intervention