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 2020-02-03 for ZINGER XT LVZRXT180J manufactured by Medtronic, Inc.
[178146603]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178146604]
It was reported that during procedure, the patient experienced coronary sinus dissection. The guidewire became stuck into the left ventricular (lv) lead during the implant attempt. When the physician tried to remove the guidewire, it unwound; became damaged and finally broke resulting in the dissection. A snare was used to remove the guidewire, but a guidewire part and was left in the coronary sinus. The lv lead was removed. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188510303]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188510304]
Additionally, it was reported that the patient became deceased within four weeks of the procedure. The cause of death was reported as worsening heart failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220452-2020-00015 |
| MDR Report Key | 9660078 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2018-11-28 |
| Date Added to Maude | 2020-02-03 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| 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 XT |
| Generic Name | OCCLUDER, CATHETER TIP |
| Product Code | DQT |
| Date Received | 2020-02-03 |
| Model Number | LVZRXT180J |
| Catalog Number | LVZRXT180J |
| Lot Number | G18A2129 |
| 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; 2. Life Threatening | 2020-02-03 |