FDA Adverse Event
Injury
Summary report: N
SENSIA SR
MDR report key: 2810545
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-05903
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS BEEN "FEELING AWFUL" SINCE THE PACEMAKER WAS IMPLANTED. PACEMAKER SYNDROME WAS SUSPECTED AS THE PATIENT WAS IN SINUS RHYTHM AND WAS IN VVI MODE. THE PATIENT'S BLOOD PRESSURE WAS TAKEN WITH AND WITHOUT PACING AND WAS NOTED TO BE HIGHER WITHOUT PACING. THE DEVICE WAS REPROGRAMMED AND 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 |
|---|---|---|---|---|---|---|---|
| 1 | SENSIA SR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | SESR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD |