FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 3153301
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05926
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- February 19, 2013
- Report Date
- March 5, 2013
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 PRODUCT: 4470 COMPETITOR IMPLANTABLE PACING LEAD (B)(6) 2012. CONCOMITANT PRODUCT: N140 COMPETITOR IMPLANTABLE PACEMAKER CARDIO/DEFIB (B)(6) 2012. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD ELEVATED THRESHOLD AND THAT THE LV LEAD HAD DISLODGED. THEREFORE, THE LV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255026 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Hospitalization| R | 0296 COMPETITOR IMPLANTABLE TACHY LEAD |