FDA Adverse Event
Malfunction
Summary report: N
ITREL 4
MDR report key: 2980169
·
Received February 27, 2013
Report
- Report Number
- 3004209178-2013-03105
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Report Date
- February 1, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3987, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37083-60, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: EXTENSION. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE NUMBER ONE ELECTRODE SHOWED "OUT OF RANGE" AFTER DEVICE IMPLANT, BUT THE DEVICE WAS REPROGRAMMED AROUND THE ELECTRODE AND GOT "ADEQUATE COVERAGE." THERE WAS NO FURTHER INFORMATION PROVIDED. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. SEE MFG REPORT #3004209178-2013-02867 FOR INITIAL IMPEDANCE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85409 | ITREL 4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO | 37703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR |