FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 194861
·
Received October 30, 1998
Report
- Report Number
- 6000030-1998-00283
- Event Type
- Injury
- Date Received
- October 30, 1998
- Date of Event
- July 27, 1997
- Report Date
- September 28, 1998
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- GZB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED FROM LEGAL DEPARTMENT. ALLEGATIONS ARE: "THE SPINAL CORD STIMULATOR CAUSED SEVERE, PAINFUL AND UNPLEASANT REACTIONS IN THE PATIENT INCLUDING: A) "FLUTTERS" OR PALPITATIONS IN THE PATIENT'S HEART; B) "ELECTRIC SHOCKS AND PAIN IN THE ABDOMINAL CAVITY & ARMS;" AND OTHER REACTIONS.... SURGERY WAS PERFORMED TO REMOVE THE HARDWARE WHICH WAS INTERACTING WITH THE GENERATOR FROM THE PATIENT'S KNEE ON DECEMBER 20, 1996. THE MEDTRONIC UNIT WAS REMOVED UNDER GENERAL ANESTHESIA AT...ON JULY 27, 1997."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 Implant | IMPLANTABLE SPINAL CORD STIMULATOR | GZB | MEDTRONIC, INC. | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other | EXPLANTED 7/27/1997| EXPLANTED 7/27/97| 1 LEAD MODEL #3888, LOT #L40898, IMPLANTED| EXTENSION MODEL 7495-51 IMPLANTED 10/22/96 |