FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 2952160
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00465
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 9, 2012
- Report Date
- November 9, 2012
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD WAS FOUND ON BOTH THE PROXIMAL AND DISTAL CONDUCTORS (NOT OBSTRUCTED). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PHYSICIAN ENCOUNTERED DIFFICULTY WHEN TRYING TO INSERT A COMPETITOR GUIDEWIRE INTO THE LEAD. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55816 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00084 YR |