FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 2964755
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-02150
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Report Date
- February 13, 2013
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. CONCOMITANT CONTINUED: 1581 COMPETITOR IMPLANTABLE TACHY LEAD (B)(6) 2005; 4470 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2005. (B)(4).
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
FOLLOW-UP INFORMATION WAS RECEIVED AND CONFIRMED THAT LV LEAD HAD CHRONICALLY HIGH THRESHOLD THAT WERE NECESSARY FOR ITS POSITION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS THE RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68234 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |