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 Code	Erosion (1750)
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 presented to the emergency after a scab over the device fell off exposing the device.It was noted the patient had intermittent trauma to the site over the previous weeks.The patient was admitted to the hospital, and the device was removed due to infection risk.The patient underwent antibiotic treatment and was released from the hospital with no sequela.It was indicated that the patient was implanted for access of cerebrospinal fluid for pk analysis.

• 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: 8653825
• Report Number: 2021898-2019-00216
• Device Sequence Number: 2663142
• Product Code: LKG
• UDI-Device Identifier: 00643169466746
• UDI-Public: 00643169466746
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K833822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

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: 12/31/2021
• Device Model Number: 44111
• Device Catalogue Number: 44111
• Device Lot Number: E26396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 05/30/2019
• 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