FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 3851379
·
Received May 22, 2014
Report
- Report Number
- 1627487-2014-26436
- Event Type
- Injury
- Date Received
- May 22, 2014
- Date of Event
- June 28, 2013
- Report Date
- May 2, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
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 HAD HIT HIS IPG SITE ON CHAIRS AND AS A RESULT THE IPG FLIPS IN THE POCKET. THE PATIENT REPORTS NO CHANGE IN STIMULATION OR COMMUNICATION. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THE SCS SYSTEM. THE PATIENT ELECTIVELY HAD THE SCS SYSTEM REMOVED BECAUSE AN MRI WAS REQUIRED TO DETERMINE THE CAUSE OF THE PATIENT'S INCREASING PAIN THAT WAS UNABLE TO TREATED WITH THE SCS SYSTEM. REPROGRAMMING WAS UNABLE TO RELIEVE THE PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306677 | EON MINI | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3912517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other | SCS LEAD, MODEL: 3189 (2)| SCS ANCHOR, MODEL: 1192 (2)| IMPLANT DATE:| IMPLANT DATE: |