FDA Adverse Event
Other
Summary report: N
ITREL
MDR report key: 210444
·
Received February 16, 1999
Report
- Report Number
- 6000032-1999-00048
- Event Type
- Other
- Date Received
- February 16, 1999
- Report Date
- January 13, 1999
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- GZB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
PATIENT IMPLANTED WITH THE ITREL II IMPLANTABLE PULSE GENERATOR FOR SPINAL CORD STIMULATION AS A THERAPY FOR CHRONIC INTRACTABLE BACK AND LIMB PAIN ON 06/06/1994. COMPLAINT RECEIVED FROM PATIENT'S ATTORNEY ON 01/13/1999 ALLEGING "AFTER THE IMPLANTATION OF THE MEDTRONIC DEVICE......PLAINTIFF INITIALLY RECEIVED PAIN RELIEF. THEREAFTER, IN LATE 1996, PLAINTIFF BEGAN EXPERIENCING EXCRUCIATING BACK PAIN AND A BURNING SENSATION.... CONSEQUENTLY, IN LATE 1996, PLAINTIFF HAD THE MEDTRONIC ITREL II SYSTEM REMOVED FROM HIS BACK AND DISCOVERED....THAT DEFENDANT HEALTH CARE PROFESSIONAL HAD IMPROPERLY PLACED THE MEDTRONIC DEVICE TOO HIGH....AND THAT SUCH DEVICE WAS UNSAFE AND DEFECTIVE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL Implant | IMPLANTABLE PULSE GENERATOR | GZB | MEDTRONIC, INC. | 7424 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other |