FDA Adverse Event Injury Summary report: N

ENTERRA

MDR report key: 3965085 · Received July 29, 2014

Report

Report Number
3007566237-2014-02106
Event Type
Injury
Date Received
July 29, 2014
Date of Event
May 19, 2003
Report Date
February 26, 2014
Manufacturer
MEDTRONIC NEUROMODULATION
Product Code
LNQ
PMA / PMN Number
H990014
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MN, US
Reporter Occupation
PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR NAUSEA, VOMITING, DEHYDRATION, AND HYPERTENSION ON (B)(6) 2003.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
441319 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization