FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 2954513
·
Received February 11, 2013
Report
- Report Number
- 2649622-2013-02262
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- December 13, 2012
- Report Date
- December 27, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, 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).
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE ROUTINE CHANGE OUT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE IMPEDANCES ON THE RIGHT VENTRICULAR LEAD WERE HIGH AND TRIGGERED AN ALERT. IT WAS DISCOVERED THE LEADS WERE NOT PLACED IN THE HEADER CORRECTLY. THE LEADS WERE RE-INSERTED INTO THE DEVICE AND REMAIN 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 |
|---|---|---|---|---|---|---|---|
| 59398 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 694758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Hospitalization| R | 4076 IMPLANTABLE PACING LEADS |