FDA Adverse Event
Injury
Summary report: N
SMARTPILL GI MONITORING SYSTEM, PHP CAPSULE
MDR report key: 1065327
·
Received June 24, 2008
Report
- Report Number
- 1320877-2008-00001
- Event Type
- Injury
- Date Received
- June 24, 2008
- Date of Event
- March 26, 2008
- Report Date
- June 23, 2008
- Manufacturer
- THE SMARTPILL CORPORATION
- Product Code
- NYV
- PMA / PMN Number
- K053547
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
GASTRIC EMPTYING EVALUATION ORDERED AS PATIENT HAS MULTIPLE GI DISORDERS AND IS CANDIDATE FOR GASTRIC NEUROSTIMATOR. INGESTED CAPSULE IN '08 AND SUBSEQUENTLY REPORTED WORSENING NAUSEA AND VOMITING. CT OF ABDOMEN SHOWED CAPSULE IN THE PYLORIC REGION. ABOUT 4 DAYS LATER, ENDOSCOPY PERFORMED AND CONFIRMED THAT THE CAPSULE WAS LODGED IN THE PYLORUS. CAPSULE SUCCESSFULLY RETRIEVED. PATIENT DISCHARGED IN THE NEXT DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTPILL GI MONITORING SYSTEM, PHP CAPSULE | NYV | THE SMARTPILL CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |