MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for PILLCAM manufactured by Given Imaging, Inc..
[126655554]
Gi fellow notified me of concerns he had with the capsule endoscopy studies. He noticed the capsule endoscopy study was very short and therefore could not report any findings because the study was incomplete. On further review of the study, it was determined the study only ran for 1:41 hours. A second study was then done on the patient. The second study ran for 7:55:30 hours after the patient swallowed a 12 hour capsule. The 2 studies were sent in to medtronic pillcam tech support to determine causes of short studies. 2 findings were reported. "bad sensor belt and shortened battery life of recorder battery". Unable to determine the bad sensor belt or shortened battery life of the recorder prior to use. Devices pulled from patient use. Manufacturer response for pill cam recorder and belt, (brand not provided) (per site reporter). Medtronic is aware and has informed us about the limited battery life although i don't think they have a response related to the sensor belt failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8054825 |
| MDR Report Key | 8054825 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-10-18 |
| 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 | PILLCAM |
| Generic Name | SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE |
| Product Code | NSI |
| Date Received | 2018-11-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 |