FDA Adverse Event
Malfunction
Summary report: N
SPRINT
MDR report key: 3863312
·
Received June 10, 2014
Report
- Report Number
- 2649622-2014-06672
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Date of Event
- August 1, 2013
- Report Date
- March 26, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 THE LAST TWO REMOTE TRANSMISSIONS HAVE SHOWN A LARGE NUMBER OF SHORT INTERVAL COUNTS (SIC) ON THE RIGHT VENTRICULAR (RV) LEAD. 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 |
|---|---|---|---|---|---|---|---|
| 338984 | SPRINT | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6945-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00062 YR | 5568-53 LEAD |