MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-06-16 for RESUME 3986ILC NA manufactured by Neuro.
[361208]
Mfr rep reported lead was broken proximal to the paddle portion. The lead was cut off, but the paddle was left in place as a reference for placing a new lead. The other end of the extension was cut off at the "bootie. " mfr rep stated portion between the paddle and the bootie was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2004-00792 |
| MDR Report Key | 530741 |
| Report Source | 07 |
| Date Received | 2004-06-16 |
| Date of Report | 2004-06-10 |
| Date Mfgr Received | 2004-06-10 |
| Device Manufacturer Date | 2003-05-01 |
| Date Added to Maude | 2004-06-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BARBARA PAHL |
| Manufacturer Street | 710 MEDTRONIC PARKWAY |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635050856 |
| Manufacturer G1 | NEURO |
| Manufacturer Street | 800 53RD AVENUE NE |
| Manufacturer City | MINNEAPOLIS MN 55421 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55421 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESUME |
| Generic Name | LEAD |
| Product Code | LHG |
| Date Received | 2004-06-16 |
| Model Number | 3986ILC |
| Catalog Number | NA |
| Lot Number | N26572 |
| ID Number | NA |
| Device Expiration Date | 2007-05-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 519979 |
| Manufacturer | NEURO |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | RESUME ILC LEAD |
| Baseline Generic Name | SURGICAL EPIDURAL LEAD |
| Baseline Model No | 3986ILC |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | STIM RESUME ILC 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. Other | 2004-06-16 |