FDA Adverse Event
Injury
Summary report: N
PRIMEADVANCED
MDR report key: 3000404
·
Received March 12, 2013
Report
- Report Number
- 9614453-2013-00561
- Event Type
- Injury
- Date Received
- March 12, 2013
- Report Date
- February 19, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD INFECTION AT THEIR DEVICE POCKET LOCATION. IT WAS ALSO REPORTED THE PATIENT HAD EXPERIENCED A BURNING SENSATION, PAIN, REDNESS AND DRAINAGE OR INCISIONAL WOUND OPENING AT THE LOCATION OF THE DEVICE POCKET. IT WAS REPORTED THE PATIENT REQUIRED MEDICAL INTERVENTION AND ANTIBIOTIC TREATMENT WAS NECESSARY. THE PATIENT WAS REPORTED TO HAVE RECOVERED WITH INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO INTERVENTIONS HAD BEEN PLANNED. THE PATIENT WAS WAITING FOR ANOTHER IMPLANT IN THE FUTURE AND WAS BEING TREATED WITH DRUGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103797 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | IPG MFG SWITZERLAND | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |