MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROGRAMMABLE VALVE INLINE UNTZ; CHPV

Catalog Number 823844

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Headache (1880); Nausea (1970); Injury (2348)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.(b)(4).

Event Description

A facility reported inability to program a hakim valve.The valve was implanted on (b)(6) 2009 and would not re-program from 50 mm h20 to 120 mm h20 on (b)(6) 2020.The patient presented symptomatic with three weeks of headaches, nausea, and dizziness; the valve was discovered stuck at 50 mmh20.The patient was taken to the operating room for a shunt revision on (b)(6) 2020 to explant the valve and place a new valve.No further patient complications were reported.

Manufacturer Narrative

Updated fields: d10, g4, g7,h2, h3, h6, h10.Unique device identifier (udi) : (b)(4).The valve was not returned for evaluation (customer did not provide shipping information) 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.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The valve was returned for evaluation: device history record (dhr) - product code 82-3844 with lot ckjbly, conformed to the specifications when released to stock failure analysis - the valve was visually inspected; the stator was dislodged.The valve could not be program or pressure tested due to the dislodged stator.The valve was dismantled and was examined under microscope at appropriate magnification: corrosion was noted on the stator.The cam magnets were controlled, magnets failed.The root cause for the programing issue reported by the customer is due to the dislodged stator.The root causes for the dislodged stator could be partly due to the corrosion on the stator.The root cause of the corrosion could not be clearly determined.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.

Event Description

N/a.

• Brand Name: PROGRAMMABLE VALVE INLINE UNTZ
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10653509
• MDR Text Key: 210591792
• Report Number: 3013886523-2020-00149
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Catalogue Number: 823844
• Device Lot Number: CKJBLY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1