MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2000-03-10 for 3986ILC manufactured by Medtronic, Inc..
[21595330]
On 3/1/2000, the pt's attorney notified the mfr that attorney has been retained to represent the interests of the pt for the malfunctioning of a cervical spinal cord stimulator... Enclosing a copy of the 2/13/1999 operative report for broken electrode of spinal cord stimulator. The neurostimulation lead was returned to the mfr for analysis on 12/20/1999.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2000-00090 |
| MDR Report Key | 269291 |
| Report Source | 00,05 |
| Date Received | 2000-03-10 |
| Date of Report | 2000-03-01 |
| Date of Event | 1999-12-13 |
| Date Mfgr Received | 2000-03-01 |
| Date Added to Maude | 2000-03-16 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | VICKI SCHREIBER |
| Manufacturer Street | 800 53RD AVE. NE |
| Manufacturer City | MINNEAPOLIS MN 55421 |
| Manufacturer Country | US |
| Manufacturer Postal | 55421 |
| Manufacturer Phone | 6125147316 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | CUSTOM REUROSTIMULATION LEAD |
| Product Code | LHG |
| Date Received | 2000-03-10 |
| Returned To Mfg | 1999-12-28 |
| Model Number | 3986ILC |
| Catalog Number | NA |
| Lot Number | N23848 |
| ID Number | NA |
| Device Expiration Date | 2003-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 260700 |
| 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 | 2000-03-10 |