MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY RESERVOIR 44111 VENTRICULAR BURR HOLE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR

Model Number 44111

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient underwent implantation of the reported device on an unreported date.In (b)(6) 2019, the patient initiated treatment with brineura for the indication of neuronal ceroid lipofuscinosis.It was stated that 2 months into treatment, the device became disconnected, and again the patient experienced a repeat disconnection between the reservoir and ventricle tubing 4 months after the first disconnection.As a result, an even smaller reservoir was placed.The reservoir has been maintained since replacement (11 months).No laboratory or diagnostic tests were reported.The reporter did not provide an assessment of the event of device dislocation in relation to treatment with brineura.The reporter assessed the event of device dislocation as related to the icv device.No other etiological factors were reported.

• Brand Name: RESERVOIR 44111 VENTRICULAR BURR HOLE
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10985214
• MDR Text Key: 220725006
• Report Number: 2021898-2020-00361
• Device Sequence Number: 1
• Product Code: LKG
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K833822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44111
• Device Catalogue Number: 44111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention