FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 4092013
·
Received August 27, 2014
Report
- Report Number
- 1627487-2014-20167
- Event Type
- Injury
- Date Received
- August 27, 2014
- Date of Event
- February 12, 2008
- Report Date
- August 7, 2014
- Manufacturer
- ST. JUDE MEDICAL, NEUROMODULATION
- Product Code
- GZB
- 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT NEVER USED HER SCS SYSTEM SINCE IMPLANT. AS A RESULT, THE SCS IPG BECAME INOPERABLE. THE SJM REPRESENTATIVE CONFIRMED THE ISSUE USING MULTIPLE EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO RESOLVE THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518719 | EON | SCS IPG | GZB | ST. JUDE MEDICAL, NEUROMODULATION | 3716 | 113373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |