FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 3991198
·
Received August 8, 2014
Report
- Report Number
- 3008973940-2014-00263
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 5, 2014
- Report Date
- June 5, 2014
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE STYLET/GUIDEWIRE WAS DAMAGED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE WAS BROKEN AND BECAME STUCK IN THE LEAD. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472386 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MEDTRONIC SINGAPORE OPERATIONS | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |