MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 43103

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records was not possible as no lot number was provided.All catheters are 100% inspected at the time of manufacture.Event and explant dates are approximations.

Event Description

It was reported to medtronic neurosurgery that the catheter was replaced due to a concern with it draining.

Manufacturer Narrative

Additional information received reported that after the implant of the catheter, there was a ¿small egg¿ under the incision, but it had not grown.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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: bob shokoohi ; 125 cremona drive; goleta, CA 93117 ; 8055718725
• MDR Report Key: 6432674
• MDR Text Key: 70856388
• Report Number: 2021898-2017-00126
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K792005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 43103
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Hospitalization; Required Intervention