MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICRO CHPV W RICKHAM UNITIZED

Model Number	82-3113
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2022
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 a hakim valve was implanted via v-p shunt on (b)(6), 2021 with unknown setting.On (b)(6), 2022, immediately after the mri examination, the set pressure changed and it became impossible to return the set pressure to the original setting.When vpv programmer was used, it got an error message and the set pressure was changed in a narrow range (approximately 120-160mmhg) under fluoroscopy.The set pressure was set to 160mmhg, and the patient's condition did not change.The physician determined that the shunt was no longer needed and the valve was removed on (b)(6), 2022.The patient was recovered.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id 823113) was returned for evaluation: device history record (dhr) - the product code 82-3113 with lot 4218853, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected a needle hole in the silicon housing was noted.The valve was hydrated.The valve was tested for programming and failed; the cam mechanism did not move.The valve was leak tested and leak from the needle hole in the silicon housing was noted.The silicon housing was cut after the valve casing.The cam mechanism was gently moved, and the valve was retested for programming and failed, the cam mechanism did not move.The valve was dismantled.The cam magnets were controlled and magnets failed.The valve was visually inspected and no defect was noted.The valve passed the test for pressure.Root cause - 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.

• Brand Name: MICRO CHPV W RICKHAM UNITIZED
• Common Device Name: CHPV
• 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: 13871649
• Report Number: 3013886523-2022-00110
• Device Sequence Number: 20006630
• Product Code: JXG
• UDI-Device Identifier: 10886704041481
• UDI-Public: (01)10886704041481(17)241031(10)4218853
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: 10/31/2024
• Device Model Number: 82-3113
• Device Catalogue Number: 823113
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2019
• 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 Sex: Female