MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for MEDTRONIC PILLCAM DR3 RECORDER manufactured by Given Imaging, Inc..
[126657975]
Gi lab fellow notified me of concerns with the capsule endoscopy studies. On further evaluation i determined the patient swallowed a 12 hour pillcam capsule (5bs-sbb-5, lot#41402x) for the capsule endoscopy. Study length after download was 8:30:13 hours, which was a shortened exam. Study sent to medtronic pillcam tech support to determine why study was shortened. Tech support report shows short battery life on recorder with 0% at end of study. There were no factors present that would have identified a shortened battery life on the recorder at the time patient swallowed capsule. I learned after speaking with medtronic representative that the recorder typically has a use life of 2 years and 400 studies. We are aware that the recorder was purchased in 2014. Manufacturer response for medtronic pillcam dr3 recorder, (brand not provided), (per site reporter). Medtronic informed us the battery was probably old, this is information that would have been helpful to know prior to putting the patient through the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8054823 |
| MDR Report Key | 8054823 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-10-19 |
| Report Date | 2018-10-22 |
| Date Reported to FDA | 2018-10-22 |
| Date Reported to Mfgr | 2018-11-09 |
| Date Added to Maude | 2018-11-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | MEDTRONIC PILLCAM DR3 RECORDER |
| Generic Name | SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE |
| Product Code | NSI |
| Date Received | 2018-11-09 |
| Lot Number | 41402X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING, INC. |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-09 |