MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Model Number	82-8804PL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Cerebral Ventriculomegaly (2133)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The certas valve was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The possible root cause for the valve setting has changed could be due to magnetic fields, as noted in the ifu: common magnets greater that 80 gauss, such as household magnets , loudspeaker magnets, and language lab headphone magnets, may affect the valve setting when placed close to the valve.
Event or Problem Description
A facility reported a certas valve was implanted on (b)(6) 2018 and imaging on (b)(6) 2020 demonstrated mild ventricular enlargement.Follow-up imaging on (b)(6) 2021 demonstrated; significant interval increase noted in ventricular enlargement.This imaging prompted an xray which demonstrated the valve setting had changed from 2 to 6.To date, all the patients visits related to hydrocephalus have been at one facility where they did not change the patients setting.The facility reported this would suggest that the setting change was not planned.The product has not been explanted and the valve was not replaced.The patient remains clinically stable.On (b)(6) 2021, the valve was dialed down from 6 (incorrect setting) to 4 with a plan to dial down from 4 to 2 (appropriate setting) in 4-6 weeks.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11779376
• Report Number: 3013886523-2021-00194
• Device Sequence Number: 3832082
• Product Code: JXG
• UDI-Device Identifier: 10886704079040
• UDI-Public: (01)10886704079040(17)230131(10)184612
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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: 01/31/2023
• Device Model Number: 82-8804PL
• Device Catalogue Number: 828804PL
• Device Lot Number: S184612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR