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

Model Number	823113
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823113) was implanted on (b)(6) 2021 for a cerebrospinal fluid diversion.The neurosurgeon was unable to reprogram the shunt.Therefore, it was removed and replaced on (b)(6), 2022.
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.
Additional Manufacturer Narrative
The hakim valve (id 823113) was returned for evaluation.Device history record (dhr) - the product code 82-3113 with lot 5775694 conformed to the specifications when released.Failure analysis - the valve was visually inspected; no defects were noted.The valve was hydrated.The valve was tested for programming, the valve failed the test.The silicone was cut just after the valve casing and the cam mechanism was gently moved.The valve was retested for programming, the valve failed the test.The valve was dismantled and was examined under microscope at appropriate magnification: bump mark was noted in the valve casing.The cam magnets were controlled and failed.The root cause for the issue reported by the customer is due to the valve receiving a hard knock and abnormal polarization of the cam magnets.The root cause for the bump marks in the valve casing noted during the investigation is due to the valve receiving a hard knock.The root cause for the abnormal polarization noted during the investigation, 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.
Event or Problem Description
N/a.

• 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: 15412546
• Report Number: 3013886523-2022-00421
• Device Sequence Number: 14926203
• Product Code: JXG
• UDI-Device Identifier: 10381780519164
• UDI-Public: (01)10381780519164(17)260731(10)5775694
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: 07/31/2026
• Device Model Number: 823113
• Device Catalogue Number: 823113
• Device Lot Number: 5775694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• 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: Unknown