FDA Adverse Event
Malfunction
Summary report: N
DEXTRUS 4137
MDR report key: 1812827
·
Received August 11, 2010
Report
- Report Number
- 1028232-2010-01725
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- June 15, 2010
- Report Date
- July 19, 2010
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVZ
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS VENTRICULAR LEAD WAS EXHIBITING INCREASED THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE. IT WAS SUSPECTED THAT THE LEAD MAY HAVE DISLODGED GOING INTO THE LEAD REVISION. ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL AS THE THRESHOLDS WERE STILL INCREASED. THE PHYSICIAN REQUESTED A NEW LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEXTRUS 4137 | PACER LEAD | NVZ | BIOTRONIK SE & CO. KG | 358764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |