FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 4831239
·
Received June 10, 2015
Report
- Report Number
- 2649622-2015-05641
- Event Type
- Malfunction
- Date Received
- June 10, 2015
- Date of Event
- March 3, 2015
- Report Date
- June 16, 2015
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE LEFT VENTRICULAR (LV) LEAD DISLODGED WHILE ATTEMPTING TO REMOVE THE SHEATH. THE LEAD WAS REMOVED AND A NEW LV LEAD WAS UTILIZED WITHOUT INCIDENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379539 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |