FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 3991631
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08013
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 22, 2014
- Report Date
- May 22, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. PRODUCTS: 694775 LEAD IMPLANTED: (B)(6) 2011; 5076-58 LEAD IMPLANTED: (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS EARLY BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE LV (LEFT VENTRICULAR) THRESHOLD WAS VERY HIGH. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471769 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00057 YR | D224TRK CRT-D |