FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 3012581
·
Received March 20, 2013
Report
- Report Number
- 3007566237-2013-00837
- Event Type
- Injury
- Date Received
- March 20, 2013
- Report Date
- February 28, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS HAVING CARDIAC ISSUES AND THE CARDIOLOGIST THOUGHT THE ISSUES WERE CAUSED BY GASTRIC STIMULATION. THE DEVICE WAS TURNED OFF AND THE CARDIAC ISSUES RESOLVED. THE COMPANY REPRESENTATIVE HAD NO FURTHER FOLLOW UP. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SENT.
Description of Event or Problem · 1
FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS MEDICATION. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116156 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC NEUROMODULATION | NEU_ENTERRA_INS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |