MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-11-24 for VERTIS PNT SAFEGUIDE LUMBAR ELECTRODE SG 101-6 * manufactured by Rs Medical.
[314275]
Incident occurred during clinical study. Physician reports that: subject who is in a study group receiving percutaneous electrical stimulation, experienced pneumothorax during their third treatment. The first two treatments were unremarkable. In the third treatment, the electrodes were placed in the usual fashion and subject complained of pleuritic type pain with shortness of breath. The electrodes were repositioned and subject was able to tolerate the remainder of the procedure. Subject was discharged from the office, and shortly thereafter called from home complaining of continued pleuritic type pain and shortness of breath. Subject was instructed to go to the emergency room for chest x-rays. Subject sought emergent treatment and cxr revealed small pneumothorax which progressed requiring inpatient admission with placement of interpleural catheter. Pneumothorax resolved, pt was discharged 2 days later and has since returned to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644243-2004-00002 |
| MDR Report Key | 557364 |
| Report Source | 05 |
| Date Received | 2004-11-24 |
| Date of Report | 2004-11-23 |
| Date of Event | 2004-11-04 |
| Date Facility Aware | 2004-11-04 |
| Report Date | 2004-11-15 |
| Date Reported to Mfgr | 2004-11-05 |
| Date Mfgr Received | 2004-11-05 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2004-12-03 |
| 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 | MIKE MCGRAW, VP |
| Manufacturer Street | 14401 SE FIRST STREET |
| Manufacturer City | VANCOUVER WA 98684 |
| Manufacturer Country | US |
| Manufacturer Postal | 98684 |
| Manufacturer Phone | 3608920339 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTIS PNT SAFEGUIDE LUMBAR ELECTRODE |
| Generic Name | FILAMENT NEEDLE ELECTRODE FOR PNT TREATMENT |
| Product Code | NHI |
| Date Received | 2004-11-24 |
| Model Number | SG 101-6 |
| Catalog Number | * |
| Lot Number | 1602041 |
| ID Number | * |
| Device Expiration Date | 2005-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 547032 |
| Manufacturer | RS MEDICAL |
| Manufacturer Address | 14401 S.E. FIRST ST. VANCOUVER WA 98684 US |
| Baseline Generic Name | PERCUTANEOUS NEUROMODULATION THERAPY DEVICE |
| Baseline Device Family | PERCUTANEOUS ELECTRICAL NERVE STIMULATOR |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K011702 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2004-11-24 |