FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 1072676
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03309
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- December 13, 2007
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWP
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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: NO ANOMALIES FOUND; FULL LEAD ANALYZED. ANALYSIS OF THE DEVICE REVEALED THAT IT DID NOT MEET EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THE CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
ASKU
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN OTW | IMPLANTABLE PACING LEAD | LWP | MEDTRONIC PUERTO RICO, INC. | 4193 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 5568 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD |