MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-05 for AMS 700 72401850 manufactured by Boston Scientific.
[94114402]
Implanted device from 2009 failed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073759 |
| MDR Report Key | 7086759 |
| Date Received | 2017-12-05 |
| Date of Report | 2017-12-04 |
| Date of Event | 2017-11-28 |
| Date Added to Maude | 2017-12-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AMS 700 |
| Generic Name | MS PUMP |
| Product Code | PIH |
| Date Received | 2017-12-05 |
| Model Number | 72401850 |
| Lot Number | 625036009 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-05 |