FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 1862871
·
Received October 9, 2010
Report
- Report Number
- 2649622-2010-10506
- Event Type
- Malfunction
- Date Received
- October 9, 2010
- Date of Event
- July 20, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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. THE FULL LEAD WAS RETURNED AND ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEFT VENTRICULAR LEAD WAS ATTEMPTED TO BE IMPLANTED. THE LEFT VENTRICULAR LEAD WAS NOT USED DUE TO PHRENIC NERVE STIMULATION. ANOTHER CHRONIC LEAD WAS UTILIZED. 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 | 80 YR | Required Intervention |