MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for RELIANCE 4-FRONT 0692 manufactured by Boston Scientific Corporation.
[185905734]
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted. The related investigation determined that this lead was associated with a reported perforation with no conclusive evidence of a malfunction; please refer to the description for more information regarding the specific circumstances of this event.
Patient Sequence No: 1, Text Type: N, H10
[185905735]
It was reported that cardiac perforation was observed during the implant of this right ventricular (rv) lead. Subsequently, this led to cardiac tamponade requiring drainage. This rv lead was successfully repositioned and remains in service. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-06340 |
| MDR Report Key | 9904964 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-09-09 |
| Date Mfgr Received | 2019-09-09 |
| Device Manufacturer Date | 2019-05-15 |
| Date Added to Maude | 2020-03-31 |
| 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 Contact | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIANCE 4-FRONT |
| Generic Name | DEFIBRILLATOR / PACEMAKER LEAD |
| Product Code | LWS |
| Date Received | 2020-03-31 |
| Model Number | 0692 |
| Catalog Number | 0692 |
| Lot Number | 554174 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2020-03-31 |