MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF- CARDIAC/PERITONEAL CATHETER, STD, BARIUM IMPR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	43103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Coma (2417)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was unavailable for return as it remains implanted.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the patient was implanted on (b)(6) 2017 due to cerebral hemorrhage and hydrocephalus.According to the report, in (b)(6) an ¿epidural effusion¿ was noted and the patient was in a coma.It was reportedly unknown if a device related issue caused or contributed to the patient¿s symptoms or coma.The patient¿s current status was reported as ¿well¿ as of (b)(6) and the device remained implanted.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF- CARDIAC/PERITONEAL CATHETER, STD, BARIUM IMPR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6495623
• Report Number: 2021898-2017-00203
• Device Sequence Number: 1269097
• Product Code: JXG
• UDI-Device Identifier: 00643169466821
• UDI-Public: 00643169466821
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K792005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2017

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: 07/31/2021
• Device Catalogue Number: 43103
• Device Lot Number: E16757
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: Life Threatening
• Patient Age: 57 YR