FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 1991316
·
Received February 15, 2011
Report
- Report Number
- 2649622-2011-02346
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- December 14, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UPGRADE TO A NEW DEFIBRILLATOR, THE PATIENT'S ATRIAL LEAD DISLODGED AND WAS REPOSITIONED. DURING THE REPOSITIONING, THE RIGHT VENTRICULAR AND LEFT SUPERIOR VENA CAVA COILS MEASURED WITH IMPEDENCE OVER 200 OHMS. SEVERAL DAYS LATER, THE PATIENT ALERT TRIGGERED. IN MEASURING THE LEAD FROM THE LEFT VENTRICULAR TIP TO THE RIGHT VENTRICULAR COIL, IMPEDENCE WAS OVER 3000 OHMS. UPON X-RAY, A LEAD FRACTURE WAS FOUND IN THE RIGHT VENTRICULAR LEAD. THE LEAD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS WERE 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 | 57 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |