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

Model Number	82-3832
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the affiliate, a hakim programmable valve became blocked after implantation.One week after implant, the valve was noted to be blocked and it was replaced with another.There is no report of further consequences to the patient.
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Udi : (b)(4).The device was received for evaluation.The position of the cam when valve was received was 40mmh2o.The valve was visually inspected: no defects were noted.The valve was tested for programming and passed the test.The valve was flushed; no occlusion was noted.The valve was leak tested; no leaks were noted.The catheters were irrigated, no occlusions noted.The valve was reflux tested and passed.The siphon guard was tested and passed the test.The siphon guard was removed.The valve was then pressure tested and passed.A review of manufacturing records found that the device conformed to specification when released to stock.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: PROGRAMMABLE VALVE IN-LINE W/SIPHONGUARD
• 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: 7736675
• Report Number: 1226348-2018-10532
• Device Sequence Number: 752219
• Product Code: JXG
• UDI-Device Identifier: 10886704041825
• UDI-Public: (01)10886704041825(10)184421
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K992173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2018

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: 01/31/2023
• Device Model Number: 82-3832
• Device Catalogue Number: 82-3832
• Device Lot Number: 184421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 10/01/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/16/2018; 10/02/2018
• 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: Required Intervention