FDA Adverse Event
Malfunction
Summary report: N
DEXTRUS 4135
MDR report key: 3002752
·
Received February 13, 2013
Report
- Report Number
- 1028232-2013-00264
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- December 6, 2012
- Report Date
- January 30, 2013
- Manufacturer
- BIOTRONIK SE & CO KG
- Product Code
- NVZ
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.
Description of Event or Problem · 1
OUS MDR - AFTER AN IMPLANT DURATION OF ABOUT 13 MONTHS INTERMITTENT UNDERSENSING AND INCREASED THRESHOLD MEASUREMENTS WERE REPORTED. THE DEVICE WAS REPROGRAMMED. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63966 | DEXTRUS 4135 | PACER LEAD | NVZ | BIOTRONIK SE & CO KG | 360303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |