FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 2053182
·
Received April 13, 2011
Report
- Report Number
- 2649622-2011-05805
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- February 1, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S24
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY FOR (B)(4): NO ANOMALIES FOUND. FULL LEAD RETURNED AND ANALYZED. ADDITIONAL FINDING OF INNER TUBING KINKED/BUCKLED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, THE RIGHT VENTRICULAR LEAD SHOWED NOISE. THE CABLES, ADAPTOR, AND PROGRAMMER WERE CHANGED BUT THE NOISE PERSISTED. THE LEAD WAS NOT IMPLANTED AND REPLACED BY ANOTHER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
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 | 63 YR | Other |