MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-20 for COMPACT DELTA LITHOTRIPTER UNIT 424 * manufactured by Dornier Medtech America, Inc..
[19679635]
Patient was admitted for left extracorporeal shock wave lithotripsy and intraoperative fluoroscopy and sonography. A total of 2500 shock waves were delivered at a power of five to the renal calculus. Pt tolerated the procedure well and was transferred to the recovery room. While in recovery the pt started to feel nauseated and faint. Her bp and hgb began to drop. The patient was then transferred to the main hospital. A ct showed a grade 2-3 splenic injury and a small laceration to the posterior aspect of the kidney. Pt was admitted to the icu awake and responsive. Pt is currently receiving blood transfusions. Pt had a 7-8 mm calculus. Pt was coupled to the lithotriptor machine and the stone was localized in the anterior, posterior as well as in the craniocaudal orientations. Shock waves were begun delivered at low energy and no ectopy was seen on kub. Serial fluoroscopy and sonography confirmed continued localization of the stone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1025964 |
| MDR Report Key | 1025964 |
| Date Received | 2008-03-20 |
| Date of Report | 2008-03-20 |
| Date of Event | 2008-03-17 |
| Report Date | 2008-03-20 |
| Date Reported to FDA | 2008-03-20 |
| Date Added to Maude | 2008-04-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT DELTA LITHOTRIPTER UNIT 424 |
| Generic Name | LITHOTRIPTER |
| Product Code | NCV |
| Date Received | 2008-03-20 |
| Returned To Mfg | 2008-03-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 992260 |
| Manufacturer | DORNIER MEDTECH AMERICA, INC. |
| Manufacturer Address | 1155 ROBERTS BLVD KENNESAW GA 30144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-03-20 |