FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 3051821
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04912
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 9, 2013
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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).
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: UPON ANALYSIS, NO ANOMALIES FOUND.
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A POTENTIAL DISSECTION OCCURRED WHEN A CATHETER WAS INSERTED INTO THE CORONARY SINUS. HOWEVER, NO APPARENT PATIENT HARM WAS REPORTED. A LEFT VENTRICULAR (LV) LEAD WAS SUBSEQUENTLY ATTEMPTED BUT COULD NOT BE POSITIONED. THE LEAD WAS NOT USED AND WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149351 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR |