FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY PLUS
MDR report key: 3992441
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09863
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- March 3, 2014
- Report Date
- June 30, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 PATIENT REPORTED WEAKNESS AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED ABNORMAL PACING IMPEDANCE. THE LV LEAD REMAINS IN USE. THE PATIENT IS ENROLLED IN THE PRODUCT SURVEILLANCE REGISTRY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 467720 | ATTAIN ABILITY PLUS | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429678 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00057 YR |