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 2019-04-24 for ZINGER MEDIUM LVZRMS180S manufactured by Medtronic, Inc.
[142929044]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142929045]
It was reported that during implant, the guidewire perforated the coronary sinus, leading to pericardial effusion and subsequent cardiac tamponade. A pericardiocentesis was performed and a sternotomy was performed to start to repair the coronary sinus. The patient then went into ventricular fibrillation (vf) with subsequent electromechanical dissociation. The patient was externally defibrillated but ultimately died. The primary cause of death was repeated vf. The patient was a participant in the electrocardiogram (ecg) belt for cardiac resynchronization therapy response clinical study. No further information was reported.
Patient Sequence No: 1, Text Type: D, B5
[144131152]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220452-2019-00050 |
| MDR Report Key | 8545157 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-04-30 |
| Date Added to Maude | 2019-04-24 |
| 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 | LISA ROBERTSON |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635262723 |
| Manufacturer G1 | MEDTRONIC, INC |
| Manufacturer Street | 37A CHERRY HILL DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZINGER MEDIUM |
| Generic Name | OCCLUDER, CATHETER TIP |
| Product Code | DQT |
| Date Received | 2019-04-24 |
| Model Number | LVZRMS180S |
| Catalog Number | LVZRMS180S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC |
| Manufacturer Address | 37A CHERRY HILL DR DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-04-24 |