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	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The certas valve was not returned for evaluation (remains implanted) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.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 root cause for the issue reported by the customer ¿could be due to mri over 3 tesla, as noted in the ifu ¿testing shows that the valve mechanism is resistant to unintended changes in the setting in a 3 tesla mri, however, the clinician should confirm the valve setting after a magnetic resonance imaging procedure.
Event or Problem Description
A facility reported an unintended shunt valve setting change after an mri.A certas valve was placed via ventricular peritoneal shunt in a patient on (b)(6) 2019.The patient had an xr performed prior to mri of lumbar spine on (b)(6) 2021 showing the valve at 7.The patient had an mri lumbar spine with an outside provider on (b)(6) 2021, after which the patients primary neurosurgeon received a call from the patient that their certas valve had changed from 7 to 8 during the mri.Skull films were not clear to the neurosurgeon.The neurosurgeon had the patient repeat skull films in their neurosurgery clinic and come in person for evaluation.Reportedly the patient was not symptomatic.The programmer confirmed the valve was at 8, the neurosurgery office staff dialed the shunt valve back down to 7 without difficulty.The patient reportedly is at their baseline function.

• 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: 11477687
• Report Number: 3013886523-2021-00116
• Device Sequence Number: 11620793
• Product Code: JXG
• UDI-Device Identifier: 10886704079040
• UDI-Public: 10886704079040
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 82-8804PL
• Device Catalogue Number: 828804PL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR