FDA Adverse Event
Injury
Summary report: N
MAGNETOM SYMPHONY
MDR report key: 1070915
·
Received July 7, 2008
Report
- Report Number
- 2240869-2008-00004
- Event Type
- Injury
- Date Received
- July 7, 2008
- Date of Event
- April 9, 2008
- Report Date
- June 9, 2008
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS USA, INC.
- Product Code
- LNH
- PMA / PMN Number
- K971684
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
A FEMALE PT CLAIMED PAIN IN HER CHEST WHILE UNDERGOING BREAST EXAM, USING CP BREAST ARRAY COIL. THE TECH ASKED HER IF SHE COULD CONTINUE THE EXAMINATION. SHE AGREED TO CONTINUE THE EXAMINATION. SHE STILL HAD PAIN AFTER SHE WENT HOME. SHE WENT TO ANOTHER HOSP WHERE SHE HAD X-RAY'S WHICH REVEALED A CHEST BONE FRACTURE. THE HOSP WAS INFORMED ABOUT THE INJURY BY THE PT WHEN SHE CAME BACK TO ASK FOR FURTHER TREATMENT (AN OPERATION). THE HOSP SUGGESTED THE FRACTURE MAY HAVE BEEN CAUSED BY LYING FACE-DOWN. THIS INCIDENT OCCURRED IN A FOREIGN COUNTRY. MR CLINICAL APPLICATIONS INSPECTED THE SYSTEM, AND THE WORKFLOW OF THE SITE AND DID NOT FIND ANY ISSUES WITH EITHER THE SYSTEM OR THE WORKFLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAGNETOM SYMPHONY | SYSTEM, NUCLEAR MAG RESONANCE IMAGING | LNH | SIEMENS MEDICAL SOLUTIONS USA, INC. | 7104594 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |