MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-29 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM XP1100 manufactured by Xoft, A Subsidiary Of Icad, Inc..
[112841571]
No device malfunction was reported for this incident. This report is filed on the basis of the physician claiming a possible side affect to the patient attributed to the iort procedure. A service record review found no system anomalies related to the patient's reported incident.
Patient Sequence No: 1, Text Type: N, H10
[112841572]
Patient underwent intraoperative brachytherapy (iort) treatment for breast cancer on (b)(6) 2018. The following day, she was admitted to (b)(6) (on (b)(6) 2018) for mild congestive heart failure with interstitial edema and trace bilateral effusions. She was released to home with oxygen life support. On follow-up with her primary care physician (pcp) on (b)(6) 2018, the physician indicated that the patient may have been fluid overloaded at the time of surgery, had an idiosyncratic reaction to the anesthetic, or an unreported side effect of the iort procedure. The physician changed the patient's blood pressure medications and the patient's symptoms were resolved. There was no reported malfunction for the brachytherapy system delivering the radiation treatment. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2018-00001 |
| MDR Report Key | 7653689 |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-29 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-06-04 |
| Date Added to Maude | 2018-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. AL YOUNG |
| Manufacturer Street | 101 NICHOLSON LANE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4084931541 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | BRACHYTHERAPY ELECTRONIC CONTROLLER |
| Product Code | JAD |
| Date Received | 2018-06-29 |
| Model Number | XP1100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDIARY OF ICAD, INC. |
| Manufacturer Address | 101 NICHOLSON LANE SAN JOSE CA 95134 US 95134 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | BRACHYTHERAPY ELECTRONIC CONTROLLER |
| Product Code | JAD |
| Date Received | 2018-06-29 |
| Model Number | XP1100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDIARY OF ICAD, INC. |
| Manufacturer Address | 101 NICHOLSON LANE SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Hospitalization | 2018-06-29 |