MEDTRONIC 3982 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-05 for MEDTRONIC 3982 * manufactured by Medtronic Inc..

Event Text Entries

[95088] Pt was hospitalized for revision spinal cord stimulating electrode and extension due to infection. During procedure an insulation break in the resume lead was found as well as signs of a healing burn.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 154614
• MDR Report Key: 154614
• Date Received: 1998-03-05
• Date of Report: 1998-02-12
• Date of Event: 1998-02-09
• Date Facility Aware: 1998-02-09
• Report Date: 1998-02-12
• Date Reported to Mfgr: 1998-02-12
• Date Added to Maude: 1998-03-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDTRONIC
• Generic Name: ELECTRODE SYMMIX
• Product Code: LHG
• Date Received: 1998-03-05
• Model Number: 3982
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 2 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 150618
• Manufacturer: MEDTRONIC INC.
• Manufacturer Address: 7000 CENTRAL AVE, NE PO BOX 1250 MINNEAPOLIS MN 55440 US
• Baseline Brand Name: SYMMIX
• Baseline Generic Name: SURGICAL EPIDURAL LEAD
• Baseline Model No: 3982
• Baseline Catalog No: NA
• Baseline ID: NA
• Baseline Device Family: STIM SYMMIX LEAD
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 48
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K913934
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1998-03-05