D
Patient 1
IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED TO REMOVE THE IMPLANTABLE STIMULATOR AS THE PATIENT HAD CONTRACTED AN INFECTION.
MAUDE MDR 2448346
- MDR report key
- 2448346
- Report number
- 0002242816-2012-00011
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-01-14
- Date received
- 2012-02-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ART KAUFMAN
- Address
- 100 INTERPACE PARKWAY PARSIPPANY NJ 07054 US
- Phone
- 983-983-9832
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-02-13 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
THE PHYSICIAN'S MANUAL/INSTRUCTIONS FOR USE INDICATE THAT IN RANDOMIZED AND NON-RANDOMIZED CLINICAL STUDIES INVOLVING 493 PATIENTS USING THE MODEL SPF-4, TWENTY-TWO ADVERSE EVENTS (4%) WERE REPORTED; OF WHICH 5 WERE FOR REPORTED INFECTION.