FDA Adverse Event
Malfunction
Summary report: N
SENSIA DR
MDR report key: 3160417
·
Received June 10, 2013
Report
- Report Number
- 3004209178-2013-10084
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- February 25, 2013
- Report Date
- March 15, 2013
- 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
- HEALTH PROFESSIONAL
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. CONCOMITANT PRODUCT: 5568, IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT ATRIAL SENSING AND VENTRICULAR SENSING WERE OCCURRING AT THE SAME TIME ON THE DEVICE PER THE ELECTROGRAM. THE ATRIAL LEAD OUTPUT HAD INCREASED DUE TO CAPTURE MANAGEMENT. IT WAS ALSO REPORTED THAT THE CAPTURE MANAGEMENT TEST SHOWED HIGH THRESHOLDS ON THE ATRIAL LEAD, BUT THE MANUAL THRESHOLD MEASUREMENT WAS WITHIN THE NORMAL RANGE. THE LEAD AND DEVICE REMAIN 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 |
|---|---|---|---|---|---|---|---|
| 259288 | SENSIA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | SEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00091 YR | 4076 IMPLANTABLE PACING LEAD |