MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1999-03-19 for RESUME ILC 3986ILC NA manufactured by Medtronic Inc..
[132060]
Sales rep reported that physician stated pt is experiencing failure of a second lead which was implanted 3 months ago. Pain has returned and stimulation is intermittent. Lead remains implanted. Add'l info being sought.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-1999-00079 |
| MDR Report Key | 215747 |
| Report Source | 07 |
| Date Received | 1999-03-19 |
| Date of Report | 1999-02-05 |
| Date of Event | 1999-02-05 |
| Date Mfgr Received | 1999-02-05 |
| Date Added to Maude | 1999-03-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESUME ILC |
| Generic Name | SURGICAL EPIDURAL LEAD |
| Product Code | LHG |
| Date Received | 1999-03-19 |
| Model Number | 3986ILC |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 209284 |
| Manufacturer | MEDTRONIC INC. |
| 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. Hospitalization; 2. Other | 1999-03-19 |