MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-10 for SOLOTRAK KR 6209BTK NA manufactured by Medtronic Inc., Cardiac Rhythm Management Division.
| Report Number | 2182208-2002-00203 |
| MDR Report Key | 831627 |
| Report Source | 05 |
| Date Received | 2005-02-10 |
| Date of Event | 2002-02-05 |
| Date Facility Aware | 2002-02-05 |
| Date Mfgr Received | 2002-02-05 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2007-03-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLOTRAK KR |
| Generic Name | PERMANENT LEAD INTRODUCER |
| Product Code | DTF |
| Date Received | 2005-02-10 |
| Model Number | 6209BTK |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 16 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 818968 |
| Manufacturer | MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION |
| Manufacturer Address | RICE CREEK CENTER 7000 CENTRAL AVE., NE / T279 MINNEAPOLIS MN 554323576 US |
| Baseline Brand Name | SOLO TRAK KR |
| Baseline Generic Name | PERMANENT LEAD INTRODUCER |
| Baseline Model No | 6209BTK |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | PERMANENT LEAD INTRODUCER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | K9513 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-10 |