FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY STRAIGHT
MDR report key: 2964461
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-02181
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- February 20, 2012
- Report Date
- December 28, 2012
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(6). (B)(4).
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 THERAPY: 6935-65 IMPLANTABLE TACHY LEAD; 5076-52 IMPLANTABLE PACING LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE PHYSICIAN ATTEMPTED TO REPOSITION WITH NO SUCCESS. THE LV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69087 | ATTAIN ABILITY STRAIGHT | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 439688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Hospitalization| R | D224TRK IMPLANTABLE BIVENTRICULAR DEFIBRILLATOR |