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

Catalog Number	41101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Therapeutic Response, Decreased (2271); Coma (2417)
Date of Event	10/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ventricular catheter was returned in two pieces of lengths 11 cm and 4 cm respectively.The tear site appeared to be jagged.It is unknown how or when the damage occurred.The returned segments were patent and passed leak testing when tested individually.The instructions for use that accompany the device cautions that low tear strength is a characteristic of most unreinforced silicone elastomer materials, and that care must be taken with the handling and placement of the silicone elastomer catheter tubing to avoid cuts, nicks, or tears.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that the patient was implanted due to a subarachnoid hemorrhage.According to the report, six days after implant, the patient had developed an infection and was in a coma.The system was explanted.As of early (b)(6), the patient still had an infection, was receiving anti-infection treatment and in a coma.
Additional Manufacturer Narrative
Additional information received reported that there was no allegation that the device caused or contributed to the patient's infection or coma.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF-VENTRICULAR 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: 6136831
• Report Number: 2021898-2016-00446
• Device Sequence Number: 1074895
• Product Code: JXG
• UDI-Device Identifier: 00643169466500
• UDI-Public: 00643169466500
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K792007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2016

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: 08/31/2020
• Device Catalogue Number: 41101
• Device Lot Number: E03960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Initial Date Received by Manufacturer: 10/31/2016
• Supplement Date Received by Manufacturer: Not provided; 04/10/2017
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 04/18/2017; 09/27/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 70