FDA Adverse Event
Death
Summary report: N
ADVISA DR MRI SURESCAN
MDR report key: 6123357
·
Received November 22, 2016
Report
- Report Number
- 2182208-2016-02605
- Event Type
- Death
- Date Received
- November 22, 2016
- Date of Event
- August 28, 2016
- Report Date
- October 24, 2016
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
(B)(6). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY FOLLOWING THE IMPLANT OF THEIR IMPLANTABLE PULSE GENERATOR (IPG). IT WAS REPORTED THAT POSTOPERATIVELY, THE PATIENT SHOWED A HEART RATE OF 48 ON THE ELECTROCARDIOGRAM MONITOR. THE PATIENT WAS MINIMALLY RESPONSE. THE PATIENT'S BLOOD PRESSURE THEN DROPPED. THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA (VT), CARDIAC ARREST AND THEN PASSED AWAY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772438 | ADVISA DR MRI SURESCAN | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC, INC. | A2DR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Death |