FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 3990728
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08505
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 29, 2014
- Report Date
- May 29, 2014
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 HIGH IMPEDANCE LEVELS AND A SUSPECTED FRACTURE OF THE PATIENTS RIGHT VENTRICULAR (RV) LEAD WERE DISCOVERED DURING A DEVICE FOLLOW-UP. THE LEAD HAS BEEN CAPPED AND NEW LEAD IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 472157 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6944-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Hospitalization| R | (B)(4), ICD |