| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DS ANTERIOR 3.0T | AC2 | INVIVO CORP | MOS | 9896-030-24082 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-02-03 | 0 | 1. O |
Patient 1
A SEDATED MALE PATIENT WAS POSITIONED FEET FIRST SUPINE AND SCANNED WITH ANTERIOR COIL FOR AN ABDOMEN EXAMINATION. AFTER THE EXAMINATION, NECROSIS OF THE SKIN ON THE UPPER RIGHT ARM WAS OBSERVED. WITH-IN A PATIENT HEATING QUESTIONNAIRE IT WAS MENTIONED THAT THE CABLE OF THE MENTIONED COIL WAS TOUCHING NEAR THE AFFECTED AREA.
Patient 1
(B)(4). METHOD, RESULTS, CONCLUSIONS: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.
Patient 1
PR#: 3(B)(4). BASED ON THE PROVIDED INFORMATION AND TESTS PERFORMED ON SITE THERE IS NO INDICATION OF A MALFUNCTION OF THE MR SYSTEM OR COIL. THE INJURY AS SUSTAINED BY THE PATIENT IS CAUSED BY A COMBINATION OF FACTORS. THE MAIN CAUSE IS CONSIDERED TO BE THE CLOSE PROXIMITY OF THE RIGHT UPPER ARM TO THE MAGNET BORE IN COMBINATION WITH THE DIRECT CONTACT WITH THE COIL CABLE TO THE AFFECTED AREA LED TO THE INJURY AS SUSTAINED BY THE PATIENT. PADDING WAS NOT USED BETWEEN THE COIL CABLE AND PATIENTS SKIN OR BETWEEN THE MAGNET BORE AND THE RIGHT UPPER ARM. OTHER FACTORS THAT CONTRIBUTED TO THE INJURY ARE: THE PATIENT HAD A HAMPERED THERMO-REGULATION AND WAS UNABLE TO ALERT THE OPERATOR BECAUSE HE WAS SEDATED. 5 SCANS ON HIGH SAR VALUE WERE CONDUCTED.