MEDTRONIC TS 46442 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-07-11 for MEDTRONIC TS 46442 * manufactured by Medtronic Ps Medical.

Event Text Entries

[149959] Upon removal of external spinal drainage system, it was noted that 0. 5cm of the catheter tip was missing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1019270
• MDR Report Key: 285561
• Date Received: 2000-07-11
• Date of Report: 2000-07-11
• Date of Event: 2000-06-10
• Date Added to Maude: 2000-07-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDTRONIC TS
• Generic Name: EXTERNAL SPINAL DRAINAGE SYSTEM
• Product Code: MAJ
• Date Received: 2000-07-11
• Model Number: 46442
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 276349
• Manufacturer: MEDTRONIC PS MEDICAL
• Manufacturer Address: 125 CREMONA DR UNIV BUSINESS CTR GOLETA CA 93117 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-07-11