FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 3990876
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08439
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 13, 2014
- Report Date
- May 13, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PHRENIC/DIAPHRAGMATIC STIMULATION DUE TO THE LEFT VENTRICULAR LEAD. THE LEAD ALSO DISLODGED - IT WOULD NOT STAY IN A USEABLE LOCATION - AND THE THRESHOLD WAS HIGH. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471031 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR |