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 2020-03-25 for ATTAIN SELECT II 6248V-130 manufactured by Medtronic, Inc..
[185933190]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185933191]
It was reported that the patient experienced hypotension, pericardial effusion, and cardiac tamponade. During implant of the left ventricular (lv) lead, the lead was successfully positioned into an acceptable venous branch (only viable one available) but dislodged twice from the branch. During a final attempt at sub-selecting the target vein with a sub-selector catheter, cardiac tamponade was diagnosed. It was also reported that a coronary sinus dissection and perforation had occurred. Medication was administered, and a pericardiocentesis was performed. The lv lead was not implanted, and lv port was capped. The patient was hospitalized for approximately one week, and was recovering well. The ra lead, rv lead and cardiac resynchronization therapy device remain in use. No further patient complications have been reported as a result of this event. The patient is a participant in a clinical study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2020-00583 |
| MDR Report Key | 9881009 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-30 |
| Date Added to Maude | 2020-03-25 |
| 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 | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTAIN SELECT II |
| Generic Name | CATHETER, PERCUTANEOUS |
| Product Code | DQY |
| Date Received | 2020-03-25 |
| Model Number | 6248V-130 |
| Catalog Number | 6248V-130 |
| 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 | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-25 |