FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3051260
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04809
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- August 7, 2012
- 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 PRODUCTS: 5076 IMPLANTABLE PACING LEAD (B)(6) 2005; 5076 IMPLANTABLE PACING LEAD (B)(6) 2007. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE ON THE HIGH VOLT AND SUPERIOR VENA CAVA COIL OF THE RIGHT VENTRICULAR LEAD. THE LEAD ALSO HAD OVERSENSING AND NOISE ON ELECTROGRAM. FLUOROSCOPY CONFIRMED A LEAD FRACTURE. THE LEAD WAS CAPPED 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 |
|---|---|---|---|---|---|---|---|
| 152168 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | D154AWG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |