FDA Adverse Event
Malfunction
Summary report: N
SENSIA SR
MDR report key: 4161600
·
Received October 10, 2014
Report
- Report Number
- 3004209178-2014-19034
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- August 27, 2014
- Report Date
- August 27, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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).
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
THE PATIENT'S DAUGHTER-IN-LAW REPORTED THAT ACCORDING TO THE PATIENT'S PHYSICAL THERAPIST, WHEN THE PATIENT EXERCISES, THE PATIENT'S HEART RATE DOES NOT APPEAR TO INCREASE ACCORDINGLY, AND THAT THE PATIENT'S HEART BEATS SLOWLY IN GENERAL. 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 |
|---|---|---|---|---|---|---|---|
| 641959 | SENSIA SR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | SESR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00093 YR | 5076-58 LEAD |