FDA Adverse Event
Malfunction
Summary report: N
OCTAD STANDARD LEAD 1X8
MDR report key: 2040899
·
Received March 23, 2011
Report
- Report Number
- 6000153-2011-02211
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 8, 2011
- Manufacturer
- MPROC, VILLALBA
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFO REPORTING DURING IMPLANT AFTER THE PHYSICIAN POSITIONED THE LEAD, HE PERFORMED IMPEDANCE TESTING AND ALL IMPEDANCES WERE > 10,000 OHMS WITH TWO TYPES OF SCREENING CABLES. THE PHYSICIAN REPLACED THE LEAD AND THE IMPLANT WAS COMPLETED. NO PT INJURY WAS REPORTED AND HE IS DOING OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTAD STANDARD LEAD 1X8 | LGW | MPROC, VILLALBA | 3877 | V10239455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |