FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 2101753
·
Received May 10, 2011
Report
- Report Number
- 3004209178-2011-03391
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- January 1, 2011
- Report Date
- April 22, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A SURGING SENSATION (B)(6) PRIOR AND AT THAT TIME SHE TURNED THE INS OFF. THERE WAS NO KNOWN RELATED ACCIDENT OR INCIDENT. IT WAS NOTED THAT THE PATIENT HAD A FALL IN (B)(6) BUT DID NOT CORRELATE THE FALL WITH ANY STIMULATION PROBLEMS. THE PATIENT MET WITH A MANUFACTURER REPRESENTATIVE FOR IMPEDANCE TESTING AND THE DEVICE WAS ON AT THE TIME OF THE MEETING. IMPEDANCE VALUES WHEN TESTED AT 3.0V AND 450MCS WERE AS FOLLOWS: C-0=4000, C-1=3337, C-2=431, C-3=3337, 0-1=3337, 0-2=4000, 0-3=4000,1-2=???, 1-3=4000, 2-3=2450 OHMS. THE OUTCOME IS UNKNOWN. FURTHER INFORMATION IS BEING REQUESTED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | EXPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL020802P| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3890, LOT# V002076| EXTENSION: MODEL 7489, LOT# NHU074310V |