MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-02-08 for MDT-SLITTER manufactured by Medtronic, Inc..
[4170164]
It was reported that the left ventricular lead dislodged. The physician elected to replace the lead. During the lead replacement procedure, the physician had difficulty accessing the coronary sinus. When the lead catheter was changed, the superior vena cava vein was unintentionally dissected. It was not known if the dissection was caused by the catheter or the introducer. The dislodged lead was removed and not replaced. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[11672186]
This event occurred outside the u. S. 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
| Report Number | 2182208-2014-00464 |
| MDR Report Key | 3617704 |
| Report Source | 01,05,07 |
| Date Received | 2014-02-08 |
| Date of Report | 2013-11-29 |
| Date of Event | 2013-11-14 |
| Date Mfgr Received | 2013-11-29 |
| Date Added to Maude | 2014-02-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NASHOANE FULWOOD-KELLEY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635260583 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM DISEASE MGMT |
| 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 | 2014-02-08 |
| Model Number | MDT-SLITTER |
| Catalog Number | MDT-SLITTER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-02-08 |