FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 2955431
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-01464
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- October 16, 2012
- Report Date
- March 12, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE LEAD HELIX WAS COMPRESSED AND BENT. VISUAL ANALYSIS NOTED APPARENT EXPLANT DAMAGE.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED EPISODES OF NOISE AND OVERSENSING. THERE WERE ALSO INSTANCES OF HIGH PACE/SENSE IMPEDANCE MEASUREMENTS. 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 |
|---|---|---|---|---|---|---|---|
| 58912 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Hospitalization| R | CD1257-40Q COMPETITOR IMPLANTABLE CARDIOVERTER DEF |