MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2005-01-10 for * 6210BTK NA manufactured by Medtronic Inc., Cardiac Rhythm Management Division.
[422887]
Pt unresponsive during implant; suspect pneumothorax.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182208-2005-00020 |
| MDR Report Key | 632759 |
| Report Source | 01,05 |
| Date Received | 2005-01-10 |
| Date of Event | 2004-11-01 |
| Date Facility Aware | 2004-11-01 |
| Date Mfgr Received | 2004-11-01 |
| Device Manufacturer Date | 2003-11-01 |
| Date Added to Maude | 2005-09-06 |
| 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 | * |
| Generic Name | PERMANENT LEAD INTRODUCER |
| Product Code | DTF |
| Date Received | 2005-01-10 |
| Model Number | 6210BTK |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 622327 |
| Manufacturer | MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION |
| Manufacturer Address | RICE CREEK CENTER 7000 CENTRAL AVE., NE / T279 MINNEAPOLIS MN *357 * S |
| Baseline Brand Name | SOLO TRAK KR |
| Baseline Generic Name | PERMANENT LEAD INTRODUCER |
| Baseline Model No | 6210BTK |
| 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 | 2005-01-10 |