MAUDE Adverse Event Report: MEDTRONIC MEXICO EDM LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	27304
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).No products have been returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a drainage device used during a procedure.It was reported that during the external lumbar drainage operation, the doctor found that the junction between the lumbar spinal canal and the drainage bag fell off during the process of implanting the material.The product was damaged.The operation went smoothly after replacing with other similar products.There was no reported delay to the procedure.There was no reported impact to the patient.Additional information was received.It was reported that the damage was located in the drainage bag where the proximal end of the patient connection catheter and the lumbar catheter were connected.

• Brand Name: EDM LUMBAR DRAINAGE KIT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13996564
• Report Number: 9612164-2022-01309
• Device Sequence Number: 14728508
• Product Code: GWM
• UDI-Device Identifier: 00763000343217
• UDI-Public: 00763000343217
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 04/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2024
• Device Model Number: 27304
• Device Catalogue Number: 27304
• Device Lot Number: 222163953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2021
• 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
• Patient Age: 64 YR
• Patient Sex: Female