FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 2940575
·
Received January 29, 2013
Report
- Report Number
- 1627487-2013-13122
- Event Type
- Injury
- Date Received
- January 29, 2013
- Date of Event
- July 1, 2012
- Report Date
- January 7, 2013
- Manufacturer
- ST. JUDE MEDICAL- NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD TURNED OFF HER STIMULATION AND DID NOT CHARGE HER IPG FOR 6 MONTHS AFTER SUFFERING A BROKEN ANKLE. THE PATIENT STATED SHE HAD DIFFICULTY CHARGING HER IPG EVER SINCE SHE TURNED IT OFF AND HAD LOST STIMULATION COVERAGE. IT WAS ALSO REPORTED THE PATIENT HAD LOST WEIGHT AND THE IPG HAD BECOME SUPERFICIAL AND VERY TENDER TO TOUCH. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39651 | EON | SCS IPG | LGW | ST. JUDE MEDICAL- NEUROMODULATION | 3716 | 55269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | SCS LEAD: MODEL 3189| IMPLANT DATE: |