FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 4160870
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-11729
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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. PRODUCT EVENT SUMMARY: A PROXIMAL PORTION WAS RECEIVED MEASURING 13.5 CM, AND THE DISTAL PORTION WAS RECEIVED MEASURING 43.5 CM WERE RECEIVED AND ANALYZED. THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD SHOWED NOISE AND OVERSENSING WITH SHORT INTERVAL COUNTS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640783 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00057 YR | Hospitalization| R | D154VWC ICD |