FDA Adverse Event Injury Summary report: N

ENTERRA

MDR report key: 3971696 · Received July 31, 2014

Report

Report Number: 3007566237-2014-02142
Event Type: Injury
Date Received: July 31, 2014
Report Date: February 24, 2014
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LNQ
PMA / PMN Number: H990014
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, 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).

Additional Manufacturer Narrative · 1

INITIAL REPORT CORRECTLY SENT AS ONE PATIENT NOT ACCOUNTED FOR EROSION INTO GASTRIC LUMEN/WALL. 7 CHANGED TO 1 DUE TO 6 REPORTS OF EROSION THAT WERE PREVIOUSLY REPORTED. SEE MANUFACTURING REPORT #'S 6000033-2001-00855, 6000033-2002-00170, 6000033-2002-00691, 2182207-2003-00705, 6000032-2004-00511, AND <(>&<)> 2182207-2004-01395.

Additional Manufacturer Narrative · 1

CORRECTION: REPORT SUBMITTED IN ERROR AS EVENT WAS PREVIOUSLY REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WERE 7 PATIENTS WITH ELECTRODE EROSION INTO THE GASTRIC LUMEN OR ABDOMINAL WALL, LEADING TO FAILURE OF THE DEVICE. IT WAS STATED THAT THE EVENTS WERE TREATED BY DEVICE REMOVAL, DEVICE REPOSITIONING, OR ANTIBIOTIC TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT HAD ELECTRODE EROSION INTO THE GASTRIC LUMEN OR ABDOMINAL WALL, LEADING TO FAILURE OF THE DEVICE. IT WAS STATED THAT THE EVENTS WERE TREATED BY DEVICE REMOVAL, DEVICE REPOSITIONING, OR ANTIBIOTIC TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
447817	ENTERRA	INTESTINAL STIMULATOR	LNQ	MEDTRONIC NEUROMODULATION	3116

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening\| R