FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 2965205
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-01581
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- October 22, 2012
- Report Date
- February 28, 2013
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WERE NO ANOMALIES FOUND.
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 PRODUCTS 6947 IMPLANTABLE TACHY LEAD (B)(6) 3023; 4076 IMPLANTABLE PACING LEAD (B)(6) 2012. (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'S LEFT VENTRICULAR (LV) LEAD HAD NO CAPTURE AND HAD DISLODGED. THE LV LEAD WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE LEAD POSSIBLY DISLODGED DUE TO THE PATIENT'S CHRONIC COUGHING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67156 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Hospitalization| R | D314TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC |