FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3992243
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09988
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 26, 2014
- Report Date
- June 26, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: (B)(4) ICD IMPLANTED: 2009 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) LEAD DEFIBRILLATION COILS HAS BEEN HIGH AND ERRATIC AND A FRACTURE IS SUSPECTED. 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 |
|---|---|---|---|---|---|---|---|
| 469376 | SPRINT QUATTRO SECURE | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00083 YR | Hospitalization| R | 5076-52 LEAD |