MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-10-15 for NONE 6208 manufactured by Medtronic, Inc..
[20229332]
It was reported that during the implant, the ability to advance the catheter through the introducer was difficult due to the introducer being too long. The patient was enrolled in the delivery for (b)(4) study. No patient complications were noted as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[20421371]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2012-03268 |
| MDR Report Key | 2791487 |
| Report Source | 05,07 |
| Date Received | 2012-10-15 |
| Date Mfgr Received | 2012-07-30 |
| Date Added to Maude | 2012-10-15 |
| 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 | 3 |
| Manufacturer Contact | RICHARD ROY |
| Manufacturer Street | CARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E. |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635262574 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONE |
| Generic Name | PERMANENT LEAD INTRODUCER |
| Product Code | DTF |
| Date Received | 2012-10-15 |
| Model Number | 6208 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | CARDIAC RHYTHM DISEASE MGMT 8200 CORAL SEA ST. N.E. MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-15 |