FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 3142204
·
Received May 29, 2013
Report
- Report Number
- 1627487-2013-01601
- Event Type
- Injury
- Date Received
- May 29, 2013
- Date of Event
- May 6, 2013
- Report Date
- August 26, 2015
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-07262012-001-C
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION 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 IS EXPERIENCING CHARGING ISSUES AND HER IPG HAS MIGRATED OUT OF THE POCKET. THE PATIENT IS REQUESTING TO HAVE HER SCS SYSTEM REMOVED. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND NOTED SHE HAS LOST A SIGNIFICANT AMOUNT OF WEIGHT AND THE IPG IS MORE SUPERFICIAL. AN SJM REPRESENTATIVE CONFIRMED HER IPG WILL NOT COMMUNICATE WITH THE CHARGER. THE PATIENT LAST USED AND CHARGED HER IPG APPROXIMATELY 1 YEAR AGO. THE PATIENT IS PENDING FOLLOW UP WITH AN SJM REPRESENTATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233966 | EON | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 64922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Required Intervention | IMPLANT DATE: | SCS LEAD, MODEL 3186| SCS LEAD, MODEL 3186| IMPLANT DATE: |