FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 1180999
·
Received September 29, 2008
Report
- Report Number
- 6000032-2008-06204
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- September 4, 2008
- Report Date
- September 29, 2008
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOR LEAD OR EXTENSION.
Description of Event or Problem · 1
IT WAS REPORTED THAT IMPEDANCES ON ELECTRODES 3 AND 4 WERE GREATER THAN 4000 OHMS AND NOT USED IN PROGRAMMING. IMPEDANCES ON ELECTRODES 1 AND 2 WERE FINE. THE PATIENT HAD GOOD THERAPEUTIC EFFECT. THE IMPLANTABLE NEUROSTIMULATOR REACHED END OF SERVICE AND NEEDED TO BE REPLACED. POST SURGICALLY IMPEDANCES ON ELECTRODES 3 AND 4 REMAINED HIGH. IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE GOOD THERAPEUTIC EFFECT AFTER SURGERY WITH THE NEW IMPLANTABLE NEUROSTIMULATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO, MED REL | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | EXTENSION: MODEL 7496| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3586 |