FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO
MDR report key: 2811721
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-15885
- Event Type
- Injury
- Date Received
- October 31, 2012
- Report Date
- September 12, 2012
- Manufacturer
- MPRI
- Product Code
- LWS
- PMA / PMN Number
- P920015/S17
- 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.
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PACE/SENSE LEAD IMPEDANCE WAS STABLE AT 1800 OHMS AND NOW HAS GRADUALLY INCREASED TO HIGH IMPEDANCE, GREATER THAN 3000 OHMS. THE LEAD REMAINS IN USE HOWEVER, THE PLAN IS TO REPLACE IT IN THE NEAR FUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MPRI | 6944 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| O| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |