FDA Adverse Event
Malfunction
Summary report: N
SENSIA
MDR report key: 2953094
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01890
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Report Date
- November 29, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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. CONCOMITANT PRODUCTS: 4074, IMPLANTABLE PACING LEAD, (B)(6) 2008. (B)(4).
Description of Event or Problem · 1
FOLLOWUP INFORMATION FROM THE CLINIC INDICATES THE DEVICE WAS FUNCTIONING NORMALLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT STATES THAT IT IS HARD TO BREATHE DURING EXERCISE AT THE UPPER PACING RATE OF 130 BEATS PER MINUTE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56318 | SENSIA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | SEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4574 IMPLANTABLE PACING LEAD |