FDA Adverse Event
Injury
Summary report: N
EON RECHARGEABLE IPG, 16-CHANNEL
MDR report key: 5272410
·
Received December 7, 2015
Report
- Report Number
- 1627487-2015-01462
- Event Type
- Injury
- Date Received
- December 7, 2015
- Report Date
- November 13, 2015
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 HIS SCS IPG SITE INCLUDING THE ILIAC CREST AND LOWER BACK REGIONS SURROUNDING THE IPG POCKET. FOLLOW-UP IDENTIFIED THE PATIENT'S SCS IPG WAS EXPLANTED AND REPLACED. IN ADDITION, A SJM REPRESENTATIVE MET WITH THE PATIENT FOR POSTOPERATIVE FOLLOW-UP AND THE PATIENT REPORTED THE PAIN IS NO LONGER PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 802634 | EON RECHARGEABLE IPG, 16-CHANNEL | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 57687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |