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

Model Number	44111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Fever (1858); Muscular Rigidity (1968); Pain (1994); Swelling (2091); Vomiting (2144); Meningitis (2389)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient was implanted with the reservoir in mid (b)(6) 2016.On (b)(6) 2018, the patient underwent a drug infusion.On (b)(6), the patient had a fever and was vomiting.The emergency department observed rigidity of the patient¿s neck and swelling of the reservoir.Also, the patient seemed to have pain when touching the reservoir and alternate episodes of drowsiness.Grade 3 meningitis was suspected and a blood test was performed with normal result (short evolution time).A cerebrospinal fluid (csf) sample was obtained from the reservoir, which was turbid.The hospital admission was decided and intravenous antibiotic therapy with cefotaxime and vancomycin was started.On (b)(6), in the morning the patient only presented with low-grade fever.Given that the analysis of csf including gram was negative, it was decided to perform a lumbar puncture that showed cell elevation (around 1000/ml) at the expense of polymorphonuclear cells and hypoglycorrhachia.It was decided to remove the (b)(4) device by surgery on (b)(6) and the patient continued with intravenous antibiotics for approximately 15 days pending the result of the cultures.A brain nuclear magnetic resonance imaging was also performed and it did not show significant alterations or intracranial complications such as abscess or obstruction to the circulation of cerebrospinal fluid.The outcome of the event was reported as recovering/resolving.It was stated the patient's (b)(4) device and the procedural puncturing of the device may have contributed to the event.It was further stated that based on the information provided, meningitis was not suspected to be caused by the study drug.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the outcome of the event was updated to recovered/resolved on (b)(6) 2018.

• Brand Name: RESERVOIR 44111 VENTRICULAR BURR HOLE
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8203277
• Report Number: 2021898-2018-00595
• Device Sequence Number: 13870646
• Product Code: LKG
• UDI-Device Identifier: 00643169466746
• UDI-Public: 00643169466746
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K833822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 44111
• Device Catalogue Number: 44111
• Device Lot Number: E05469
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 12 YR