FDA Adverse Event
Malfunction
Summary report: N
EON
MDR report key: 2971573
·
Received January 30, 2013
Report
- Report Number
- 1627487-2013-05159
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Date of Event
- January 10, 2013
- Report Date
- January 10, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- K010032
- 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 CHARGER AND PROGRAMMER ARE UNABLE TO COMMUNICATE WITH THE IPG. IN TURN, THE PT HAS LOST STIMULATION. THE PT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41738 | EON | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 113358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | SCS EXTENSION: MODEL 3383| IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3183 |