FDA Adverse Event
Injury
Summary report: N
ATTAIN PERFORMA
MDR report key: 4833916
·
Received June 10, 2015
Report
- Report Number
- 2649622-2015-06879
- Event Type
- Injury
- Date Received
- June 10, 2015
- Date of Event
- April 2, 2015
- Report Date
- April 3, 2015
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE LV LEAD WAS REPOSITIONED AND IT REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378060 | ATTAIN PERFORMA | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00034 YR | Hospitalization| R | 5076-52 LEAD/6947M62, LEAD/DTBB1QQ BI-V ICD |