FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 2833652
·
Received November 12, 2012
Report
- Report Number
- 1627487-2012-11665
- Event Type
- Injury
- Date Received
- November 12, 2012
- Date of Event
- October 17, 2012
- Report Date
- March 17, 2016
- 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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 2. REFERENCE MFR REPORT: 1627487-2012-11666. THE PT REPORTED HE WAS EXPERIENCING HEATING WHILE CHARGING AFTER 20 MINS, AND WAS UNABLE TO CHARGE THE IPG UNTIL IT WAS FULLY CHARGED. IN ADDITION, THE PT WAS CONCERNED HIS IPG MAY BE SUPERFICIAL. ATTEMPTS TO CONTACT THE PT WERE UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 3152661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male | Required Intervention | IMPLANT:| IMPLANT:| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192 (3)| SCS EXTENSION: MODEL 3342| SCS LEAD: MODEL 3146 (2)| SCS LEAD: MODEL 3186| SCS LEAD: MODEL 3186| SCS LEAD: MODEL 3146 (2)| SCS EXTENSION: MODEL 3342| IMPLANT:| IMPLANT:| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192 (3) |