FDA Adverse Event
Injury
Summary report: N
LUMAX 340 DR-T
MDR report key: 1991986
·
Received February 7, 2011
Report
- Report Number
- 1028232-2011-00253
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- November 29, 2010
- Report Date
- January 26, 2011
- Manufacturer
- BIOTRONIK, SE & CO. KG
- Product Code
- MRM
- PMA / PMN Number
- P000009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PER IMPACT ADVERSE EVENT REPORT, THE PATIENT COMPLAINED OF INCREASING SENSITIVITY AT PECTORAL SITE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 AND A POCKET REVISION WAS SUCCESSFULLY COMPLETED. ALL RECORDS INDICATE THAT THIS DEVICE REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 340 DR-T | ICD LEAD | MRM | BIOTRONIK, SE & CO. KG | 355267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization |