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

Model Number 44111

Device Problem Fluid/Blood Leak (1250)

Patient Problems Cerebrospinal Fluid Leakage (1772); Edema (1820); Swelling (2091)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant prods and therapy dates: brineura (cerliponase alfa) solution for infusion; dose: unknown, icv; therapy date: (b)(6) 2017 to unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

On an unspecified date, an ommaya 12 mm reservoir, model # 44111 was implanted.On an unspecified date in (b)(6) 2017, the patient initiated treatment with brineura (dose and frequency were not reported, icv) for the indication of neuronal ceroid lipofuscinosis.The most recent dose was administered on an unspecified date.On an unspecified date, the patient came in for an infusion.It was noted that the ommaya site looked edematous and was highly suspicious of a device leakage.A cerebrospinal fluid (csf) culture showed red blood cell (rbc) 11, white blood cell (wbc) 131, and protein 139.2 mg/dl (units and reference range not reported).Culture showed no growth after one day.No treatment for the event was reported.The action taken with brineura due to the event was not reported.The outcome of the event was not reported.The event was assessed as related to the patient's ommaya reservoir device.

Manufacturer Narrative

Concomitant prods and therapy dates: brineura (cerliponase alfa) solution for infusion; dose 300mg, qow, icv; therapy date: (b)(6) 2017 to unknown date.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that on (b)(6) 2017, the patient initiated treatment with brineura (300 mg, qow).On (b)(6) 2018, at the clinic, the patient's ommaya reservoir site was noted to be soft with swelling and fluid around the area.No redness or external leakage was noted.His vital signs were within normal limits and his behavior was normal and at baseline.A neurosurgeon was consulted and the diagnosis was early pseudomeningocele around the reservoir; perhaps hydrocephalus of the communicating type or related to infusion.No action taken was with brineura due to the event.The outcome of the event was reported as recovering/resolved.

• Brand Name: RESERVOIR 44111 VENTRICULAR BURR HOLE
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7454793
• MDR Text Key: 106736990
• Report Number: 2021898-2018-00221
• Device Sequence Number: 1
• Product Code: LKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• 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: 05/14/2018
• 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 Age: 5 YR
• Patient Weight: 20