MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-04-06 for EXABLATE 2000 * manufactured by Insightec, Ltd..
[446711]
The pt experienced moderate pain in the coccyx and buttocks during treatment, but did not stop treatment at any stage and received only 50 mg of pethidine for analgesia. Although thermal response to each sonication was variable, all sonications appeared well within the boundaries of the fibroid. Treatment was stopped when the pt complained of pain radiating to the left leg and catheter tip. In recovery the lady complained of a sensation of numbness in the left buttock. On closer exam she was found to have decreased sensation throughout the peri-anal and perineal region as well as the posterior left thigh. She had leaked some fecal matter, but anal tone was normal on rectal exam. Power, tone, reflexes and distal sensation were all within normal limits. A further mri of the pelvis and lumbar spine was carried out which demonstrated no evidence of thecal sac compression. Hyperintensity of the piriformis muscle and surrounding tissues was identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615058-2005-00001 |
| MDR Report Key | 702970 |
| Report Source | 01,07 |
| Date Received | 2006-04-06 |
| Date of Report | 2006-04-06 |
| Date of Event | 2005-05-06 |
| Device Manufacturer Date | 2005-02-01 |
| Date Added to Maude | 2006-04-25 |
| 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 | 0 |
| Manufacturer Contact | DOV MAOR, VICE PRESIDENT |
| Manufacturer Street | 5 NACHUM HETH STREET PO BOX 2039 |
| Manufacturer City | TIRAT CARMEL 31290 |
| Manufacturer Country | IS |
| Manufacturer Postal | 31290 |
| Manufacturer Phone | 9724813131 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXABLATE 2000 |
| Generic Name | FOCUSED ULTRASOUND |
| Product Code | MIK |
| Date Received | 2006-04-06 |
| Model Number | EXABLATE 2000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 692101 |
| Manufacturer | INSIGHTEC, LTD. |
| Manufacturer Address | 5 NACHUM HETH STREET PO BOX 2059 TIRAT CARMEL IS 39120 |
| Baseline Brand Name | MK2 - EXABLATE |
| Baseline Generic Name | NA |
| Baseline Model No | EXABLATE 2000 |
| Baseline Catalog No | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-04-06 |