MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Model Number	82-3162
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A physician reported the set pressure of a hakim valve (id 823162) unintentionally changed after mri examination.The valve was implanted via v-p shunt on (b)(6) 2012 with setting 80mmh2o in a (b)(6) year-old male patient.The set pressure was not changed since it was implanted.It could not be changed by using neodymium.However, the patient's symptoms worsened so the valve was removed and replaced on (b)(6) 2022.
Additional Manufacturer Narrative
The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the product code 82-3162 with lot cnjcc6, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; a cut/tear in the needle chamber was noted.The position of the cam when valve was received was 80mmh2o.The valve was hydrated.The valve was tested for programming and failed the test, the cam mechanism just wiggled a little bit during the programming process.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for occlusion, reflux, siphon guard and pressure.The valve was retested for programming and failed the test, the cam mechanism wiggled a little bit during the programming process.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was noted on the spring, on the cam mechanism and on the base plate.The cam magnets were controlled and failed.The root cause for the programing issue reported by the customer is due to the abnormal polarization of the cam magnets the root cause for the abnormal polarization was probably caused by an exposition of a too strong magnetic field, as noted in the ifu, ¿any magnet may experience a degradation of magnetic field strength as a consequence of exposure to the significantly stronger magnet field induced in a mri procedure.The root cause for the cut/tear in the silicone housing is probably due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14084163
• Report Number: 3013886523-2022-00148
• Device Sequence Number: 2148187
• Product Code: JXG
• UDI-Device Identifier: 10886704041559
• UDI-Public: (01)10886704041559(17)170731(10)CNJCC6
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 82-3162
• Device Catalogue Number: 823162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Male