MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-11-03 for MEDTRONIC, INC. manufactured by .
[2021647]
On (b)(6) 2008, patient underwent placement of single chamber permanent pacemaker. Per md, vendor representative handed md an expired (7/08) product without checking the packaging and the device was implanted. Md to disclose incident to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2123407 |
| MDR Report Key | 2123407 |
| Report Source | 99 |
| Date Received | 2008-11-03 |
| Date of Report | 2008-10-31 |
| Date of Event | 2008-10-21 |
| Date Facility Aware | 2008-10-23 |
| Report Date | 2008-10-31 |
| Date Reported to FDA | 2008-11-03 |
| Date Reported to Mfgr | 2008-10-21 |
| Date Added to Maude | 2011-06-16 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC, INC. |
| Generic Name | 52CM SINGLE CHAMBER PACEMAKER |
| Product Code | LWO |
| Date Received | 2008-11-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-11-03 |