FDA Adverse Event
Injury
Summary report: N
EON MINI
MDR report key: 3960981
·
Received July 22, 2014
Report
- Report Number
- 1627487-2014-15559
- Event Type
- Injury
- Date Received
- July 22, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 2, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-07262012-002-R
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RECALL #: 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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 EXPERIENCED PAIN AT THE IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2014 AND THE IPG SITE WAS REVISED. PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429074 | EON MINI | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3108397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Other | SCS LEAD: MODEL 3219| IMPLANT LEAD: |