FDA Adverse Event
Injury
Summary report: N
ITREL
MDR report key: 1102743
·
Received August 8, 2008
Report
- Report Number
- 2950887-2008-04714
- 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). IN THREE DIABETIC PATIENTS WITH RENAL FAILURE AND DIALYSIS, THE TEMPORARY INCREASE OF NAUSEA IN ASSOCIATION WITH RENAL IMPAIRMENT RESPONDED TO AN INCREASE OF DIALYSIS FREQUENCY. ONE PATIENT HAD DIALYTIC TREATMENT WHEN ENTERING THE STUDY. TWO PATIENTS STARTED DIALYTIC TREATMENT AFTER IMPLANTATION.
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 | UNK | Required Intervention | LEAD (X2) MODEL 4300 LOT# UNK IMPLANTED| EXPLANTED |