FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 1072755
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03524
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- April 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: NO ANOMALIES WERE FOUND; THERE IS ONLY ONE SET OF SETSCREW MARKS ON THE IS-1 CONNECTOR PIN OF THE LEAD AND IT IS TOO PROXIMAL WHICH INDICATES THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE. FULL LEAD WAS RETURNED AND ANALYZED.
Description of Event or Problem · 1
ASKU
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO SECURE | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6947 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |