FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE S
MDR report key: 3990411
·
Received August 7, 2014
Report
- Report Number
- 2649622-2014-08665
- Event Type
- Malfunction
- Date Received
- August 7, 2014
- Date of Event
- May 6, 2014
- Report Date
- June 19, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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. PRODUCTS: 407652 LEAD IMPLANTED 2013 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SUDDEN RISE IN THRESHOLD AND THE THRESHOLD MEASUREMENT WAS DESCRIBED AS ELEVATED. THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE PRODUCT (B)(4) STUDY NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464233 | SPRINT QUATTRO SECURE S | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6935M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | (B)(4) ICD |