FDA Adverse Event
Malfunction
Summary report: N
SENSIA SR
MDR report key: 3861990
·
Received June 10, 2014
Report
- Report Number
- 3004209178-2014-11124
- Event Type
- Malfunction
- Date Received
- June 10, 2014
- Report Date
- April 24, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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
THE PATIENT REPORTED SWELLING AT THE DEVICE SITE AND THAT THE DEVICE VIBRATES OR IS NOT STEADY ALL THE TIME. THE PATIENT BELIEVES THIS IS DUE TO A TRANSFORMER IN THE PATIENT¿S GARAGE. 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 |
|---|---|---|---|---|---|---|---|
| 338791 | SENSIA SR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | SESR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | 4076-58 LEAD |