FDA Adverse Event
Injury
Summary report: N
EON MINI IMPLANTABLE PULSE GENERATOR
MDR report key: 1962738
·
Received January 13, 2011
Report
- Report Number
- 1627487-2011-02048
- Event Type
- Injury
- Date Received
- January 13, 2011
- Date of Event
- December 15, 2010
- Report Date
- December 15, 2010
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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
DEVICE 1 OF 3. REFERENCE MFR REPORTS: 1627487-2011-02049 AND 1627487-2011-02050. THE PT RECEIVED HER SCS SYS, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS, ON (B)(6) 2009. IT WAS REPORTED THE SCS SYS WAS EXPLANTED AND NOT REPLACED DUE TO INEFFECTIVE STIMULATION. ACCORDING TO THE PT, THE SCS THERAPIES COVERED THE DESIRED AREAS BUT WOULD "FADE" SHORTLY AFTER EACH REPROGRAMMING SESSION. THE EXPLANTED PRODUCTS WERE RETURNED TO THE MFR FOR ANALYSIS. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI IMPLANTABLE PULSE GENERATOR | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 2865303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |