MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for ALTRUA PACEMAKER manufactured by Boston Scientific Corporation.
[139300139]
Biventricular lead extraction and replacement with a new lead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084989 |
| MDR Report Key | 8432548 |
| Date Received | 2019-03-18 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-28 |
| Date Added to Maude | 2019-03-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALTRUA PACEMAKER |
| Generic Name | PACEMAKER / ICD / CRT NON-IMPLANTABLE / COMPONENTS |
| Product Code | OSR |
| Date Received | 2019-03-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Brand Name | CRDM NON-DEFIB LEAD DEXTRUS |
| Generic Name | DRUG-ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE |
| Product Code | NVN |
| Date Received | 2019-03-18 |
| Model Number | 4136 |
| Catalog Number | 358754 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-18 |