FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEUROMODULATION DEVICE
MDR report key: 2983333
·
Received February 28, 2013
Report
- Report Number
- 3007566237-2013-00627
- Event Type
- Injury
- Date Received
- February 28, 2013
- Report Date
- April 2, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
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
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A SCAR ALL THE WAY DOWN HER BACK DUE TO THE STIMULATION AND THE HCP¿S ¿OWN CONTRAPTION¿. IT WAS STATED THAT ¿INSTEAD OF WAKING UP WITH A LITTLE CUT ON HER BUTT WOKE UP WITH ALL THE WAY DOWN THE BACK AND ACROSS¿ BECAUSE THE HCP PUT IN HIS OWN CONTRAPTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S ORIGINAL IMPLANTING HCP CUT FROM HER SHOULDER BLADES ALL THE WAY DOWN TO HER BUTTOCK REGION. ONCE THE PATIENT WAS DONE WITH THE SURGERY SHE WAS IN THE HOSPITAL FOR 7 DAYS, AND THEN HAD TO GO TO REHAB. THE PATIENT STATED THAT THE HCP "MADE HIS OWN DEVICE UP." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86825 | UNKNOWN NEUROMODULATION DEVICE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |