MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-04 for DLP CARDIAC SUMP 12112 manufactured by Medtronic.
[4744808]
Patient underwent urgent repair of enlarging ascending aortic aneurysm on (b)(6) 2011. Procedure was uneventful. Patient underwent lower extremity workup in (b)(6) 2014. Imaging revealed claudication in left leg and an ovoid metallic foreign body within the lumen of the left superficial artery. On (b)(6) 2014, patient underwent left pelvic angiogram, right sided approach; left superficial artery cutdown, removal of foreign body, interposition superficial femoral artery-reverse greater saphenous vein bypass; harvest of greater saphenous vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038124 |
| MDR Report Key | 4080824 |
| Date Received | 2014-09-04 |
| Date of Report | 2014-09-04 |
| Date of Event | 2011-01-07 |
| Date Added to Maude | 2014-09-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DLP CARDIAC SUMP |
| Generic Name | DLP CARDIAC SUMP |
| Product Code | DTS |
| Date Received | 2014-09-04 |
| Model Number | 12112 |
| Lot Number | 2010062157, 2010102507 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS 55432 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-04 |