MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-06-15 for RESUME ILC LEAD 3986ILC NA manufactured by Medtronic Inc..
[109081]
Report received with explanted devices stating that the pt was experiencing a "jolting" feeling on low amplitudes, and that there was a question of a possible lead fracture or electrical leak. It was also noted that the physician had "trimmed both leads" prior to implantation, against the advice of the manufacturer's rep present at implantation. Device analysis is ongoing as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-1998-00156 |
| MDR Report Key | 173216 |
| Report Source | 05 |
| Date Received | 1998-06-15 |
| Date of Report | 1998-05-05 |
| Date of Event | 1998-03-23 |
| Date Mfgr Received | 1998-05-05 |
| Device Manufacturer Date | 1997-12-01 |
| Date Added to Maude | 1998-06-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESUME ILC LEAD |
| Generic Name | SURGICAL EPIDURAL LEAD |
| Product Code | LHG |
| Date Received | 1998-06-15 |
| Returned To Mfg | 1998-05-05 |
| Model Number | 3986ILC |
| Catalog Number | NA |
| Lot Number | N23199 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2.5 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 168424 |
| 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. Other | 1998-06-15 |