FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 3992110
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-10033
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 2, 2014
- Report Date
- June 3, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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. MODEL: 5076-45, LEAD; IMPLANT: 2010-(B)(6), MODEL: 5076-52, LEAD; IMPLANT: 2010-(B)(6), MODEL: 6935M55, LEAD; IMPLANT: 2014-(B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PHRENIC NERVE STIMULATION (PNS) WAS EVIDENT ON THE PATIENTS LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REPLACED. THE PNS REMAINS EVIDENT ON THE NEWLY PLACED LV LEAD. THE 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 |
|---|---|---|---|---|---|---|---|
| 469457 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Hospitalization| R | DTBA1D4, ICD |