FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY PLUS
MDR report key: 3992995
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09560
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 19, 2014
- Report Date
- June 19, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, 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 MEDICAL PRODUCTS: DTBA1D4 DEVICE, IMPLANTED (B)(6) 2014; 5076-45 LEAD, IMPLANTED (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE IMPLANT PROCEDURE THE PATIENT WENT FOR A CHEST X-RAY. AFTER THE X-RAY IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS COILED IN THE ATRIUM. THE LEAD WAS EXPLANTED AND REPLACED THE FOLLOWING DAY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468102 | ATTAIN ABILITY PLUS | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429678 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Hospitalization| R | 6947M55 LEAD |