FDA Adverse Event
Other
Summary report: N
ITREL
MDR report key: 257718
·
Received January 4, 2000
Report
- Report Number
- 6000032-2000-00006
- Event Type
- Other
- Date Received
- January 4, 2000
- Report Date
- November 22, 1999
- Manufacturer
- MEDTRONIC INC.
- Product Code
- GZB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT WAS IMPLANTED WITH AN ITREL NEUROSTIMULATOR ON 8/25/1999 FOR CHRONIC INTRACTABLE PAIN OF THE TRUNK AND LIMBS. THE PT EXPERIENCED PAINFUL STIMULATION AFTER GOING THROUGH SECURITY DEVICES AT RETAIL STORES. THE PT WAS ADVISED TO AVOID SECURITY DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL | IMPLANTABLE PULSE GENERATOR | GZB | MEDTRONIC INC. | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other | LEAD MODEL 388728, LOT NUMBER L67770, IMPLANTED| 08/25/1999, STATUS UNK. EXTENSION MODEL 7495-25,| IMPLANTED 08/25/1999, STATUS UNK. |