FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 5060911
·
Received September 8, 2015
Report
- Report Number
- 3004209178-2015-17438
- Event Type
- Injury
- Date Received
- September 8, 2015
- Report Date
- August 13, 2015
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD; PRODUCT ID 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
A HEALTHCARE PROVIDER REPORTED THAT A PATIENT IMPLANTED FOR GASTROINTESTINAL/PELVIC FLOOR WAS HAVING ISSUES WITH GASTROPARESIS. CURRENTLY THE PATIENT WAS IN THE HOSPITAL FOR NAUSEA AND VOMITING. DEVICE REPROGRAMMING WAS DONE. NO FOLLOW-UP CONTACT, EVENT DATE, POTENTIAL EVENT CAUSE, INTERVENTIONS, OR OUTCOME WAS REPORTED. NO FOLLOW-UP WAS ABLE TO BE CONDUCTED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 593886 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |