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

Model Number	82-3113
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the hakim microvalve could not be programmed after mri and was revised.The valve was implanted to the patient via vp-shunt; however, initial settings are unknown.The pressure setting could not change after mri.The revision surgery was performed.There was no adverse consequence to the patient and no further information was provided by hospital reported.The product will be returned to your site.
Additional Manufacturer Narrative
The device was returned for evaluation.The position of the cam when valve was received was 110mmh2o.The valve was visually inspected: no defects noted.The valve was tested for programming; the valve passed the test.The valve was flushed; no occlusion was noted.The valve was leak and reflux tested; no issues found.The catheter was irrigated; no occlusions noted.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: HAKIM MICRO VALVE
• 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: 7718122
• Report Number: 1226348-2018-10507
• Device Sequence Number: 19149819
• Product Code: JXG
• UDI-Device Identifier: 10886704041481
• UDI-Public: (01)10886704041481(11)210421(17)220228(10)126537(17)PZP035
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K980778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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: 02/28/2022
• Device Model Number: 82-3113
• Device Catalogue Number: 82-3113
• Device Lot Number: 126537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 09/26/2018
• 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