FDA Adverse Event
Malfunction
Summary report: N
OCTAD STANDARD LEAD 1X8
MDR report key: 2040919
·
Received March 23, 2011
Report
- Report Number
- 6000153-2011-02213
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 8, 2011
- Manufacturer
- MPROC, VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P96009
- 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 THE PHYSICIAN HAD DIFFICULTY POSITIONING THE LEAD AND WHILE SHE WAS INSERTING THE STYLET INTO THE LEAD SHE NOTICED THAT THE OUTER INSULATION SEEMED TO BE SCRAPED. THE LEAD WAS REPLACED WITH TWO OTHER LEADS AND THE IMPLANT WAS COMPLETED. PT IS DOING OKAY AND NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTAD STANDARD LEAD 1X8 | MHY | MPROC, VILLALBA | 3877 | V10345443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |