MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-15 for MEDTRONIC PHRENIC NERVE PAD UNK manufactured by Medtronic Usa, Inc.
[18821215]
Pt underwent aortic valve replacement and single vessel coronary artery bypass. Post operatively pt returned to surgery for re-exploration of mediastinal bleeding. Pt coded nine days later and expired. Pt also had tia the day before. During autopsy on 05/2002, a phrenic nerve pad was noted to be retained in the pericardial space adjacent to the heart.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 394944 |
| MDR Report Key | 394944 |
| Date Received | 2002-05-15 |
| Date of Report | 2002-05-15 |
| Date of Event | 2002-04-22 |
| Date Facility Aware | 2002-05-02 |
| Report Date | 2002-05-15 |
| Date Reported to FDA | 2002-05-15 |
| Date Reported to Mfgr | 2002-05-15 |
| Date Added to Maude | 2002-05-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC PHRENIC NERVE PAD |
| Generic Name | PHRENIC NERVE PAD |
| Product Code | GZE |
| Date Received | 2002-05-15 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 383955 |
| Manufacturer | MEDTRONIC USA, INC |
| Manufacturer Address | 7000 CENTREAL AVE MINNEAPOLIS MN 544323576 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-15 |