FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1172984
·
Received September 19, 2008
Report
- Report Number
- 3004209178-2008-05929
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- July 1, 2008
- Report Date
- August 21, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A KICKING SENSATION WHEN HER DEVICE WAS ON. THIS STARTED APPROXIMATELY ONE MONTH AGO AT THE STIMULATOR SITE. THE PATIENT CANNOT THINK OF AN EVENT THAT WAS ASSOCIATED WITH THE ADVENT OF THE SENSATION. THE IMPEDANCE MEASUREMENTS WERE CHECKED TWICE AND WERE NORMAL. ANYTHING PAIRED WITH ELECTRODE 0 HAD AN IMPEDANCE OF 2398 OHMS (UPPER LIMIT OF NORMAL). THE KICKING SENSATION WAS STRONGEST WHEN ANYTHING WAS PAIRED WITH ELECTRODE 0 AND THEN DISSIPATED AS THEY PROGRAMMED AWAY FROM ELECTRODE 0, DOWN THE LEAD TO ELECTRODE 2 AND 3. PALPATION REVEALED THE AREA AROUND THE IPG WAS VERY TENDER. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | IMPLANTED:| LEAD: MODEL 3889| PROGRAMMER: MODEL 3037| EXPLANTED: |