FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 2954712
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-02405
- Event Type
- Injury
- Date Received
- February 11, 2013
- Report Date
- December 28, 2012
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND THE DEVICE SET WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT THE PATIENT SUSTAINED AN EXTERNAL INJURY TO THE IMPLANT SITE AND SELF-TREATED FOR TWO WEEKS. THE PATIENT NOTIFIED THE OFFICE WHEN THE DEVICE AND LEADS WERE ERODING THROUGH THE SKIN. THE PATIENT WAS HOSPITALIZED AND RECEIVED ANTIBIOTIC THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58815 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD |