FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 1924206
·
Received December 14, 2010
Report
- Report Number
- 2649622-2010-13462
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- July 28, 2009
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS LATER REPORTED THAT THE PATIENT HAD EXIT BLOCK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD AN ELEVATED THRESHOLD AT IMPLANT AND WAS NOTED AS ELEVATED TWO ADDITIONAL TIMES. IT WAS ALSO REPORTED THAT THE LEAD REMAINS IN USE DESPITE DIAPHRAGMATIC STIMULATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 4196 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other | COMPETITOR IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6944 IMPLANTABLE TACHY LEAD |