FDA Adverse Event
Injury
Summary report: N
MAXIMO VR
MDR report key: 3992312
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14867
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 16, 2014
- Report Date
- June 16, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 A SUPERIOR VENA CAVA (SVC) ALERT WAS OBSERVED ON THE DEVICE. THE SVC PORT ON THE DEVICE IS PLUGGED, AS THERE IS A RIGHT VENTRICULAR (RV) COIL-ONLY LEAD CURRENTLY ACTIVE. THE ALERT WAS CLEARED. THE DEVICE 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 |
|---|---|---|---|---|---|---|---|
| 467034 | MAXIMO VR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7232CX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Required Intervention | 7232CX ICD |