FDA Adverse Event
Injury
Summary report: N
ASKU
MDR report key: 1861561
·
Received October 8, 2010
Report
- Report Number
- 2182208-2010-00722
- Event Type
- Injury
- Date Received
- October 8, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. EVALUATION SUMMARY: INNER INSULATION BREACHED. ALL CONDUCTORS HAD BLOOD, OUTER INSULATION KINKED/BUCKLED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE LEAD WAS RETURNED TO THE MANUFACTURER WITH NO INFORMATION, ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC, INC. | LEAD/MEDT | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |