FDA Adverse Event
Injury
Summary report: N
DEXTRUS 4136
MDR report key: 1001013
·
Received February 20, 2008
Report
- Report Number
- 1028232-2008-00090
- Event Type
- Injury
- Date Received
- February 20, 2008
- Date of Event
- November 1, 2007
- Report Date
- January 18, 2008
- Manufacturer
- BIOTRONIK GMBH AND CO
- Product Code
- DTB
- 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. THEREFORE, THE ANALYSIS IS 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. REVIEW OF THE QUALITY DOCUMENTS SHOWED A REGULAR MANUFACTURING PROCESS.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECIEVED INFO THAT THE RIGHT VENTRICULAR (RV) LEAD HAD BECOME DISLODGED AND WAS UNABLE TO CAPTURE APPROPRIATELY. IT WAS DECIDED TO REVISE THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEXTRUS 4136 | PACER LEAD | DTB | BIOTRONIK GMBH AND CO | 358754 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |