MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-07 for DR3 DATA RECORDER manufactured by Given/medtronic.
[49408354]
Unable to download patient data from the given/medtronics dr3 data recorder. Error message on the computer download screen states that the check-in failed. Diagnosis or reason for use: capsule endoscopy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063333 |
| MDR Report Key | 5784888 |
| Date Received | 2016-07-07 |
| Date of Report | 2016-07-07 |
| Date of Event | 2016-07-01 |
| Date Added to Maude | 2016-07-12 |
| 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 | DR3 DATA RECORDER |
| Generic Name | PILLCAM RECORDER |
| Product Code | NSI |
| Date Received | 2016-07-07 |
| Returned To Mfg | 2016-07-07 |
| Model Number | DR3 DATA RECORDER |
| Lot Number | 2015-07 DR3-081 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN/MEDTRONIC |
| Manufacturer Address | 2 HACARMEL ST. YOKNEAM IL 20692 US 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-07 |