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

Model Number	82-3184
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A lot number has been provided.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the ous affiliate,the hakim right angle programmable valve had unexpected setting changes after implantation.In (b)(6) 2018 the valve was programmed to 70 and later, the valve was confirmed at 30 via x-ray, then in (b)(6) 2018 the valve was set to 70 and later confirmed to be at 50 via x-ray.The valve was again reprogrammed to 70; however, for a third time, it was discovered at a different setting, 30 confirmed via x-ray.There is no report of device revision.It was also reported that the patient has not undergone any fresh mri or travel anywhere flight or involve any activity that can hamper the setting.
Additional Manufacturer Narrative
Udi: (b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed as 'no complaint sample returned to codman for evaluation'.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.

• Brand Name: HAKIM PROGRAMMABLE VALVE, RT ANGLE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle, CH240 0; SZ CH2400
• MDR Report Key: 7719420
• Report Number: 1226348-2018-10512
• Device Sequence Number: 10989048
• Product Code: JXG
• UDI-Device Identifier: 10886704041580
• UDI-Public: (01)10886704041580(10)138439
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 82-3184
• Device Catalogue Number: 82-3184
• Device Lot Number: 138439
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other