FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 3992626
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09768
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 29, 2014
- Report Date
- June 11, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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. CONCOMITANT: 5076-52 LEAD IMPLANTED: 2011-(B)(6); COMPETITOR LEAD IMPLANTED: 2011-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD BEEN IMPLANTED AFTER THE USE BEFORE DATE. THE LEAD 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 |
|---|---|---|---|---|---|---|---|
| 470778 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00042 YR | DTBA1D1 ICD |