MAUDE Adverse Event Report: MEDTRONIC DOMINICANA BIOGLIDE®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	93522
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Codes	Fever (1858); Inflammation (1932)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a catheter.It was reported that the patient underwent ventriculoperitoneal shunt surgery with laparoscopic assistance.Postoperatively, the patient developed a low-grade fever.After adjusting the setting to 2.5, the anti-infection treatment was effective.However, when adjusted to 1.5, the fever could not be controlled.Abdominal ct showed localized thickening around the peritoneal end of the drainage tube.The drainage tube was removed, and flushing revealed damage to the drainage tube.The fever was considered to be caused by aseptic inflammation in the abdominal muscles due to cerebrospinal fluid leakage from the damaged drainage tube.The catheter was replaced was a new one.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3.Product analysis determined that the visual inspection confirmed the catheter had been damaged/cut.The returned product did not meet the requirements for patency and leak testing.All catheters are 100% inspected at the time of manufacture.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BIOGLIDE®
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 4620 n. beach st.; fort worth, TX 76137 ; 7635265677
• MDR Report Key: 24079777
• Report Number: 9612501-2026-00106
• Device Sequence Number: 20303226
• Product Code: JXG
• UDI-Device Identifier: 00763000027605
• UDI-Public: (01)00763000027605(17)290915(10)0230282661
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K792005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 93522
• Device Catalogue Number: 93522
• Device Lot Number: 0230282661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 01/19/2026; 03/05/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 01/20/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 80 KG