FDA Adverse Event
Injury
Summary report: N
IEON MINI
MDR report key: 4202691
·
Received October 22, 2014
Report
- Report Number
- 1627487-2014-26881
- Event Type
- Injury
- Date Received
- October 22, 2014
- Date of Event
- September 12, 2014
- Report Date
- October 2, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Removal / Correction Number
- 1627487-12192011-003-R
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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
IT WAS REPORTED THE IPG IS UNABLE TO COMMUNICATE WITH THE EXTERNAL DEVICES. THE PT IS NO LONGER RECEIVING STIMULATION. THE SJM REP CONFIRMED THE ISSUE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673842 | IEON MINI | SCS IPG | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3350879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other | IMPLANT DATE:| SCS LEAD: MODEL 3228 |