MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-01-19 for MAGNATHERM MODEL 1000 manufactured by International Medical Electronics, Ltd..
[216043]
A user facility reported to the company that a pt with one of their implanted neurostimulators for parkinsons disease was treated with a magnatherm model 1000 over or close to area of implant and electrode wire. Pt became comatose. Magnatherm instruction manual states under no circumstances should shortwave diathermy be used to treat areas containing implanted devices similar to this or the electrode wires of such devices. The dr reported to the company that the magnatherm 1000 shortwave diathermy was operating properly and the company has no reason to believe otherwise. Also, diathermy is contraindicated for use in areas with metallic implants.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1921974-2001-00001 |
| MDR Report Key | 313400 |
| Report Source | 00 |
| Date Received | 2001-01-19 |
| Date of Report | 2001-01-19 |
| Date of Event | 2001-01-05 |
| Date Mfgr Received | 2001-01-18 |
| Device Manufacturer Date | 1979-07-01 |
| Date Added to Maude | 2001-01-26 |
| 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 | 0 |
| Manufacturer Street | 3939 BROADWAY |
| Manufacturer City | KANSAS CITY MO 64111 |
| Manufacturer Country | US |
| Manufacturer Postal | 64111 |
| Manufacturer Phone | 8169315358 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNATHERM MODEL 1000 |
| Generic Name | SHORTWAVE DIATHERMY |
| Product Code | IMJ |
| Date Received | 2001-01-19 |
| Model Number | 1000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 303112 |
| Manufacturer | INTERNATIONAL MEDICAL ELECTRONICS, LTD. |
| Manufacturer Address | 3939 BROADWAY KANSAS CITY MO 64111 US |
| Baseline Brand Name | MAGNATHERM MODEL 1000 |
| Baseline Generic Name | SHORTWAVE DIATHERMY |
| Baseline Model No | 1000 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | MAGNATHERM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2001-01-19 |