FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO
MDR report key: 3153065
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05795
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 3, 2013
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, 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). CONCOMITANT PRODUCT 5076 IMPLANTABLE PACING LEAD (B)(6) 2002.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAD INCREASED FROM 496 OHMS TO 1072 OHMS AND TRIGGERED AN ALERT. THE THRESHOLD HAD INCREASED FROM 2V TO 3.5V. AN X-RAY WAS REQUESTED AND THERE WAS NO SIGN OF FRACTURE. A SUBSEQUENT INTERROGATION A FEW WEEKS LATER SHOWED HIGH IMPEDANCE. THE LEAD 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 |
|---|---|---|---|---|---|---|---|
| 254851 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR | D154AWG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |