MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-04-30 for * 3986ILC NA manufactured by Medtronic Inc..
[179316]
Pt was no longer experiencing appropriate stimulation from lead, and instead had "jolting" sensation when she moved certain ways. A copy of the pt's x-ray provided by the physician showed a sharp bend beneath the paddle portion of the lead. The device has been returned to the mfr, and is presently undergoing analysis.
Patient Sequence No: 1, Text Type: D, B5
[7828122]
H6 - preliminary device analysis was not available as of the date of this report. Final device analysis will be sent in follow-up report when analysis has been completed. H6-final device analysis revealed all multiple conductors/wires broken. Further analyiss revealed fractures of all conductors via fatigue initiating immediate to the crimp ferrule.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182207-1998-00102 |
| MDR Report Key | 166038 |
| Report Source | 05 |
| Date Received | 1998-04-30 |
| Date of Report | 1998-03-26 |
| Date of Event | 1998-02-27 |
| Device Manufacturer Date | 1997-07-01 |
| Date Added to Maude | 1998-05-07 |
| 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 | KATHY SIMPSON |
| 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 | * |
| Generic Name | NEUROSTIMULATION LEAD |
| Product Code | LHG |
| Date Received | 1998-04-30 |
| Returned To Mfg | 1998-03-26 |
| Model Number | 3986ILC |
| Catalog Number | NA |
| Lot Number | N23036 |
| ID Number | NA |
| Device Expiration Date | 2001-07-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 161584 |
| 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 | 1998-04-30 |