FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 3992986
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09577
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 19, 2014
- Report Date
- June 19, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. CONCOMITANT MEDICAL PRODUCTS: DDBB1D1 ICD, IMPLANTED (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH IMPEDANCE AND NON-PHYSIOLOGIC NOISE SHORTLY AFTER IMPLANT WHEN THE PATIENT PRESENTED AFTER HEARING AN ALERT. THE POCKET WAS RE-OPENED AND IT WAS DISCOVERED THAT THE LEAD PIN WAS NOT FULLY INSERTED PAST THE SET SCREW OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE LEAD WAS SECURED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472379 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 693558 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00087 YR | Hospitalization| R | 5076-45 LEAD |