FDA Adverse Event
Injury
Summary report: N
ITREL
MDR report key: 1102703
·
Received August 8, 2008
Report
- Report Number
- 2950887-2008-04820
- Event Type
- Injury
- Date Received
- August 8, 2008
- Report Date
- May 20, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
LITERATURE REFERENCE: ANDERSSON S, ET AL. "GASTRIC ELECTRICAL STIMULATION FOR INTRACTABLE VOMITING IN PATIENTS WITH CHRONIC INTESTINAL PSEUDOOBSTRUCTION". NEUROGASTROENTEROL MOTIL 2006; 18(9):823-30. PATIENT DIARIES, HOSPITAL RECORDS AND INVESTIGATION RESULTS BEFORE AND AFTER TREATMENT WERE STUDIED AND COMPARED TO EVALUATE THE LONG-TERM EFFECT OF GASTRIC ELECTRICAL STIMULATION (GES). ONE PATIENT WITH A MARKED EFFECT OF GES FOR SEVERAL YEARS HAD A SEVERE DETERIORATION OF THE DISEASE BEFORE THE EIGHT YEARS CONTROL WITH CHRONIC SEPTICEMY, RENAL INSUFFICIENCY, CARDIAC AND RESPIRATORY FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL | LNQ | MEDTRONIC NEUROMODULATION | 7424 OR 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| LEAD (X2) MODEL 4300 LOT# UNK IMPLANTED |