MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-10 for LEGEND II 8426 manufactured by Mdt Sofamor Danek Puerto Rico Mfg.
[22140590]
It was reported that the 20 year old device had no magnet response and there was no telemetry. The device remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[22366037]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647346-2013-00154 |
| MDR Report Key | 3510145 |
| Report Source | 05,07 |
| Date Received | 2013-12-10 |
| Date of Report | 2013-10-09 |
| Date of Event | 2013-10-09 |
| Date Mfgr Received | 2013-10-09 |
| Date Added to Maude | 2014-03-24 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NASHOANE FULWOOD-KELLEY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635260583 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM DISEASE MGMT |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGEND II |
| Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE |
| Product Code | LWO |
| Date Received | 2013-12-10 |
| Model Number | 8426 |
| Catalog Number | 8426 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT SOFAMOR DANEK PUERTO RICO MFG |
| Manufacturer Address | HUMACAO PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5024 | 2013-12-10 |