MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-05 for MDT-SLITTER manufactured by Medtronic, Inc..
[23549798]
This event occurred outside the us where the same model is distributed. All information provided is included in this report. Patient information is not generally available due to confidentiality concerns. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23549799]
It was reported that during the implant procedure of the left ventricular (lv) lead, after all the leads were placed, physician slit the lv sheath and the lv lead completely dislodged from the posterior-lateral vein. The lv lead was removed and exchanged for another lead. Physician believed the event was related to the sheath and slitter. No patient complications have been reported as a result of this event. The patient is a participant in the sensor optimization of cardiac resynchronization therapy response clinical study.
Patient Sequence No: 1, Text Type: D, B5
[33121421]
Patient Sequence No: 1, Text Type: N, H10
[33121422]
It was further reported that patient encountered a hematoma and sandbag placed over right femoral artery puncture performed, no treatment was necessary. Pi assessed event as research procedure related and not serious.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2015-02448 |
| MDR Report Key | 4970302 |
| Date Received | 2015-08-05 |
| Date of Report | 2015-05-13 |
| Date of Event | 2015-05-13 |
| Date Mfgr Received | 2015-09-01 |
| Date Added to Maude | 2015-08-05 |
| 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 | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
| Manufacturer Street | 8200 CORAL SEA ST 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 |
| Generic Name | MAGNET, TEST, PACEMAKER |
| Product Code | DTG |
| Date Received | 2015-08-05 |
| Model Number | MDT-SLITTER |
| Catalog Number | MDT-SLITTER |
| 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 | 2015-08-05 |