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	Obstruction of Flow (2423)
Health Effect - Clinical Code	Missing Value Reason (3192)
Date of Event	06/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.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 and was explanted.Another hakim was used to replace.
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.The provided lot number is not valid for the product code provided; therefore, a review of manufacturing records could not be performed based on the provided information.
Additional Manufacturer Narrative
(b)(4).The device was returned for evaluation.The position of the cam when valve was received was 160mmh2o.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 and reflux tested without issue.The valve was then pressure tested and passed.A review of manufacturing records found no discrepancies when the device was 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: 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: 7719554
• Report Number: 1226348-2018-10513
• Device Sequence Number: 903939
• Product Code: JXG
• UDI-Device Identifier: 10886704041580
• UDI-Public: (01)10886704041580(10)140411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974739
• 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): 06/30/2018

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 Model Number: 82-3184
• Device Catalogue Number: 82-3184
• Device Lot Number: 140411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 06/30/2018
• Supplement Date Received by Manufacturer: 07/26/2018; 09/26/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/16/2018; 09/27/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention