FDA Adverse Event
Injury
Summary report: N
LUMOS DR-T
MDR report key: 756914
·
Received August 30, 2006
Report
- Report Number
- 1028232-2006-00174
- Event Type
- Injury
- Date Received
- August 30, 2006
- Date of Event
- August 7, 2006
- Report Date
- August 22, 2006
- Manufacturer
- BIOTRONIK GMBH AND CO,
- Product Code
- LWS
- PMA / PMN Number
- P000009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DEVICE AND LEAD SYSTEM WERE EXPLANTED DUE TO INFECTION. NO REPLACEMENT SYSTEM IMPLANTED. THE SYSTEM WAS RETURNED. NON-COMPLIANT PT. HEAVY PHYSICAL ACTIVITY OCCURRED POST IMPLANT DISLODGING THE LEAD. THIS ALSO HAPPENED AFTER REPOSITIONING REQUIRING HOSPITALIZATION TO PREVENT ACTIVITY THAT DISLODGED THE LEAD. SECOND REPOSITIONING SUCCESSFUL, BUT INFECTION OCCURRED DUE TO MULTIPLE PROCEDURES. THIS IS PART OF A SYSTEM. SELOX JT-45, MDR 1028232-06-0176 AND KENTROX SL 65/16, MDR 1028232-06-0175.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMOS DR-T | ICD | LWS | BIOTRONIK GMBH AND CO, | 353220 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization |