MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-05-13 for LITHOSTAR MODULARIS 05531103 NA manufactured by Siemens Ag.
[19281222]
It was reported that a male patient was treated on a mobile lithotripsy unit located at the hospital. The patient received 4,000 shocks, at 90 shocks per minute, at power level 4. The procedure was for an eswl for treatment of a left renal stone. The patient had stopped taking his coumadin seven days prior to the treatment, and at that time had normal coagulation (pt). His platelets showed a low normal level. The following day, the patient went to the er complaining of pain and discomfort. The hospital performed and mri, and diagnosed the patient with a ruptured spleen. The stone was still present. The patient elected to have the stone surgically removed, and the hospital removed the spleen as well. The doctor reported that the injury was related to the treatment. The system was checked by service, and again by siemens service. The system checked out as operating properly, and it was determined that the procedure was performed within normal parameters. Two cases were done that day. The first case was completed without incident.
Patient Sequence No: 1, Text Type: D, B5
[19424709]
Selection of adequate therapy parameters is the responsibility of the operator, and is dependent on the patient's condition/state of health. Medical publications state that ruptured spleen is a known, but rare adverse effect of eswl. It is not system specific, but eswl application specific. It was reported by the customer that the patient recovered from his 2 surgeries ok.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2240869-2009-00018 |
| MDR Report Key | 1381867 |
| Report Source | 06 |
| Date Received | 2009-05-13 |
| Date of Report | 2009-05-12 |
| Date of Event | 2009-03-06 |
| Date Mfgr Received | 2009-04-24 |
| Date Added to Maude | 2009-05-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL VAN RYN |
| Manufacturer Street | 51 VALLEY STREAM PKWY. MS G-01 |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104484634 |
| Manufacturer G1 | SIEMENS AG |
| Manufacturer Street | 127 HENKESTRASSE |
| Manufacturer City | ERLANGEN 91052 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHOSTAR MODULARIS |
| Generic Name | TABLE, CYSTOMETRIC ELECTRIC |
| Product Code | MMZ |
| Date Received | 2009-05-13 |
| Model Number | 05531103 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS AG |
| Manufacturer Address | 127 HENKESTRASSE ERLANGEN 91052 GM 91052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2009-05-13 |