FDA Adverse Event
Malfunction
Summary report: N
SENSIA SR
MDR report key: 1990850
·
Received February 15, 2011
Report
- Report Number
- 6000144-2011-00783
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 THE VENTRICULAR CAPTURE MANAGEMENT OF THE DEVICE WAS SHOWING HIGH THRESHOLDS. THE MANUAL THRESHOLDS WERE CONSISTENTLY ACCEPTABLE. 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 |
|---|---|---|---|---|---|---|---|
| 1 | SENSIA SR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | SESR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Other | (B)(4) IMPLANTABLE PACING LEAD |