FDA Adverse Event
Injury
Summary report: N
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
MDR report key: 3152657
·
Received June 7, 2013
Report
- Report Number
- 2649622-2013-06706
- Event Type
- Injury
- Date Received
- June 7, 2013
- Date of Event
- April 18, 2013
- Report Date
- April 24, 2013
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- 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. CONCOMITANT PRODUCT: 6947 IMPLANTABLE TACHY LEAD (B)(6) 2009;5076 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED SOON AFTER IMPLANT. THE LV LEAD WAS ATTEMPTED TO BE REPOSITIONED, HOWEVER THE CORONARY WIRE WOULD NOT PASS DOWN THE LEAD. 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 |
|---|---|---|---|---|---|---|---|
| 253194 | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR | Hospitalization| R | D314TRG IMPLANTABLE PACEMAKER CARDIO/DEFIB |