MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-06-07 for SYMPHONY 2550 manufactured by Ela Medical.
[20760129]
After one day of implantation, the device involved in this mdr report was explanted and returned because the atrial pacing pulse led to the ventricular depolarisation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610579-2005-00033 |
| MDR Report Key | 611393 |
| Report Source | 05,07 |
| Date Received | 2005-06-07 |
| Date of Report | 2005-06-07 |
| Date of Event | 2005-05-11 |
| Report Date | 2005-06-07 |
| Date Mfgr Received | 2005-05-11 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2005-06-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | CA LA BOURSIDIERE |
| Manufacturer City | LE PLESSIE ROBINSON 92357 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92357 |
| Manufacturer Phone | 146013687 |
| Manufacturer G1 | ELA MEDICAL |
| Manufacturer Street | 99 RUE MAURICE ARNOUX |
| Manufacturer City | MONTROUGE 92120 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMPHONY |
| Generic Name | IMPLANTABLE CARDIAC PACEMAKER |
| Product Code | DYX |
| Date Received | 2005-06-07 |
| Returned To Mfg | 2005-05-19 |
| Model Number | 2550 |
| Catalog Number | 2550 |
| Lot Number | S050415 |
| ID Number | * |
| Device Expiration Date | 2006-10-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 601189 |
| Manufacturer | ELA MEDICAL |
| Manufacturer Address | * MONTROUGE FR |
| Baseline Brand Name | SYMPHONY |
| Baseline Generic Name | IMPLANTABLE CARDIAC PACEMAKER |
| Baseline Model No | 2550 |
| Baseline Catalog No | 2550 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2005-06-07 |