MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Model Number	823162
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.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
This is 3 of 4 reports linked to mfg report numbers: 3013886523-2021-00580, 3013886523-2021-00581, 3013886523-2021-00583.It was reported four patients were implanted with hakim valve (id 823162) and developed hydromas (overdrain).The valves were set at 120mmh2o and then adjusted to the higher setting (140mmh2o) to resolve the hydroma.Patients symptoms were resolved after the programming reset.
Additional Manufacturer Narrative
Additional information received: (b)(6) 2021 - surgery.(b)(6) 2021 postoperative day 1 "ct" head looked okay.(b)(6) 2021- postoperative appointment, ambulation improved but "stm" (short term memory) loss did not.And wanted to consider dropping her setting so a "ct" head was ordered.(b)(6) 2021- "ct" head looked okay.(b)(6) 2021- postoperative appointment, shunt adjusted to 100, another "ct" head ordered.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id 823162) was not returned for evaluation (remains implanted), therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined, however, the possible root cause for ¿developed hydromas ( overdrained)¿ issue reported by the customer could be due to a wrong adjustment.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.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• 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: 13174566
• Report Number: 3013886523-2021-00582
• Device Sequence Number: 4561812
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)250930(10)5038015
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2022

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: 09/20/2025
• Device Model Number: 823162
• Device Catalogue Number: 823162
• Device Lot Number: 5038015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 01/17/2022; 03/09/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/04/2022; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• 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