FDA Adverse Event
Malfunction
Summary report: N
SPECIFY
MDR report key: 1041328
·
Received May 9, 2008
Report
- Report Number
- 2182207-2008-02494
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 8, 2008
- Report Date
- April 9, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- K971756
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A LACK OF THERAPY BENEFIT; THE PATIENT HAD GONE TO THE ER FOR TREATMENT RELATED TO STIMULATION SENSATION DETECTED IN THE CHEST AREA. THE PATIENT TURNED STIMULATION THERAPY OFF, WHICH RESOLVED THE ISSUE. FOLLOW-UP WITH THE HCP FOR X-RAY EXAM OF THE LEAD AND SYSTEM REPROGRAMMING WAS ANTICIPATED. THE PATIENT STATUS WAS FAIR; THE PATIENT HAD RETURNED HOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECIFY | GZB | MEDTRONIC NEUROMODULATION | 3998 | LB3541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| PROGRAMMER MODEL 7435| EXPLANTED:| EXTENSION MODEL 7495LZ LOT #NHK019432V| IMPLANTABLE NEURO STIMULATOR MODEL 7427| EXTENSION MODEL 7495LZ| LOT # NFE131104H| EXPLANTED: |