MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-12-13 for ITREL 3986ILC NA manufactured by Medtronic Inc...
[240517]
Hcp reported patient experienced burning at generator, shocking & intermittent stimulation since implant. At time of explant it was noted that the insulation had pulled away from lead body exposing wires. The device was explanted and returned to the manufacturer for analysis. A follow up report will be sent when additional information is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000030-2001-00967 |
| MDR Report Key | 367264 |
| Report Source | 05 |
| Date Received | 2001-12-13 |
| Date of Report | 2001-08-01 |
| Date of Event | 2001-07-24 |
| Date Mfgr Received | 2001-08-01 |
| Device Manufacturer Date | 2000-02-01 |
| Date Added to Maude | 2001-12-26 |
| 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 | 3 |
| Manufacturer Contact | VICKI SCHREIBER |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55421 |
| Manufacturer Country | US |
| Manufacturer Postal | 55421 |
| Manufacturer Phone | 7635147316 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ITREL |
| Generic Name | LEAD |
| Product Code | LHG |
| Date Received | 2001-12-13 |
| Returned To Mfg | 2001-10-15 |
| Model Number | 3986ILC |
| Catalog Number | NA |
| Lot Number | N24261 |
| ID Number | NA |
| Device Expiration Date | 2004-02-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 356386 |
| 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 | 2001-12-13 |