FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 2812594
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16937
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 8, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED AND ANALYZED. THE OUTER INSULATION HAD A BREACHED CUT. ALL CONDUCTORS, INCLUDING THE DISTAL CONDUCTOR, HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). VISUAL ANALYSIS REVEALED THE LEAD WAS DAMAGED AT IMPLANT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE LEFT VENTRICULAR (LV) LEAD WAS DAMAGED BY THE SLITTER. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN ABILITY | IMPLANTABLE PACING LEAD | OJX | MEDTRONIC PUERTO RICO, INC. | 4196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other | 0125 COMPETITOR IMPLANTABLE TACHY LEAD |