FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 3981587
·
Received August 5, 2014
Report
- Report Number
- 3007566237-2014-02188
- Event Type
- Injury
- Date Received
- August 5, 2014
- Report Date
- June 21, 2010
- 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
CORRECTION: REPORT SUBMITTED IN ERROR AS IT IS A DUPLICATE OF A FIELD ACTION. EVENTS WERE CAPTURED AND REPORTED IN THE FOLLOWING MANUFACTURER REPORTS: 3004209178-2009-00625, 2182207-2007-00700, 2182207-2004-01480, AND 2182207-2008-02050.
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 4351, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. 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 FOUR PATIENTS HAD BOWEL OBSTRUCTION AND/OR PERFORATION OF THE BOWEL ASSOCIATED WITH THE LEADS. EVENTS REQUIRED SURGICAL INTERVENTION AND THE PATIENTS RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 456640 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC NEUROMODULATION | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |