FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 2131962
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10613
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- March 10, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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): NO ANOMALIES FOUND, HOWEVER THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED); FULL LEAD RETURNED AND ANALYZED.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD WAS TOO SMALL FOR THE SELECTED VEIN. THE LEAD WAS NOT IMPLANTED AND A DIFFERENT 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 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other | 1688TC COMPETITOR IMPLANTABLE PACING LEAD| 1688TC COMPETITOR IMPLANTABLE PACING LEAD| 0185 COMPETITOR IMPLANTABLE TACHY LEAD| 0185 COMPETITOR IMPLANTABLE TACHY LEAD| N119 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB| N119 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB |