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