FDA Adverse Event
Injury
Summary report: N
EMS SWISS LITHOCLAST LITHOTRIPTER
MDR report key: 2514254
·
Received April 3, 2012
Report
- Report Number
- 3005099803-2012-01159
- Event Type
- Injury
- Date Received
- April 3, 2012
- Date of Event
- March 8, 2012
- Report Date
- March 9, 2012
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FFK
- PMA / PMN Number
- K963285
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROBE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THERE WAS AN UNSPECIFIED ERROR CODE AND THE PATIENT EXPERIENCED ARRHYTHMIA. ALTHOUGH AN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL FOLLOW UP, THERE IS NO FURTHER INFORMATION REGARDING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EMS SWISS LITHOCLAST LITHOTRIPTER | LITHOTRIPTOR, ELECTRO-HYDRAULIC | FFK | BOSTON SCIENTIFIC - MARLBOROUGH | UNK212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |