FDA Adverse Event
Injury
Summary report: N
DEXTRUS 4135
MDR report key: 2974062
·
Received February 13, 2013
Report
- Report Number
- 1028232-2013-00221
- Event Type
- Injury
- Date Received
- February 13, 2013
- Date of Event
- November 12, 2012
- Report Date
- January 28, 2013
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- DTB
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE DEFORMATION OF THE OUTER COIL OCCURRED MOST LIKELY DURING THE EXPLANT PROCEDURE. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD HAD DISLODGED AND WAS REMOVED. THE PHYSICIAN IMPLANTED A LONGER LEAD, INSTEAD, FOR MORE STABILITY. NO COMPLICATIONS WERE NOTED. NO ADVERSE PT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64082 | DEXTRUS 4135 | PACER LEAD | DTB | BIOTRONIK SE & CO. KG | 358744 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |