FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY PLUS
MDR report key: 3993881
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09054
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- July 31, 2013
- Report Date
- June 17, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 THAT THE LEFT VENTRICULAR (LV) LEAD WAS ATTEMPTED TO IMPLANT BUT WAS NOT USED DUE TO DISLODGEMENT. THREE ATTEMPTS TO LEAVE THE LEAD IN THE INTER-VENTRICULAR GROOVE RESULTED IN DISLODGEMENT WHEN THE SHEATH WAS PULLED. NO OTHER LV LEAD WAS IMPLANTED DUE TO THE PATIENT¿S ANATOMY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470207 | ATTAIN ABILITY PLUS | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00085 YR |