FDA Adverse Event
Death
Summary report: N
LUMAX 540 HF-T
MDR report key: 2213126
·
Received August 5, 2011
Report
- Report Number
- 1028232-2011-01749
- Event Type
- Death
- Date Received
- August 5, 2011
- Date of Event
- September 15, 2010
- Report Date
- July 26, 2011
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- LWS
- PMA / PMN Number
- P050023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THIS PT REPORTED TO THE OFFICE WITH A HEMATOMA ON THE PACEMAKER SITE. KEFLEX WAS ADMINISTERED AND THE HEMATOMA CLEARED, WITHOUT INTERVENTION, AFTER SEVERAL DOSES OF ANTIBIOTICS ON (B)(6) 2010. IT WAS LATER REPORTED TO US THAT THIS PT EXPIRED IN THE HOSPITAL DUE TO CARDIAC ARREST (B)(6) 2011. NO ADD'L INFO IS AVAILABLE AT THIS TIME. SHOULD ADD'L INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMAX 540 HF-T | CRT-D | LWS | BIOTRONIK SE & CO. KG | 360347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Death |