FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 1203511
·
Received October 17, 2008
Report
- Report Number
- 3004209178-2008-06622
- Event Type
- Malfunction
- Date Received
- October 17, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 14, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORTS IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS TURNING ON AND OFF. IT WAS ALSO REPORTED THAT WHEN THE STIMULATION WAS TURNED ON THE PATIENT EXPERIENCED CHEST DISCOMFORT. THE PATIENT'S STATUS WAS REPORTED AS GOOD. NO PATIENT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | IMPLANTED:| EXTENSION: MODEL 7489| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888| PROGRAMMER: MODEL 7434A |