FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY PLUS
MDR report key: 3153356
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05968
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 8, 2013
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING INITIAL IMPLANT, THE LEFT VENTRICULAR (LV) LEAD DISLODGED BEFORE SLITTING. THE LEAD WAS REMOVED AND REPLACED WITH ANOTHER LV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258014 | ATTAIN ABILITY PLUS | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429678 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR |