FDA Adverse Event
Malfunction
Summary report: N
EON RECHARGEABLE IPG
MDR report key: 2190953
·
Received July 19, 2011
Report
- Report Number
- 1627487-2011-01767
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Manufacturer
- ST JUDE NEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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
THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2008. IT WAS REPORTED THAT THE PT CAN NO LONGER ESTABLISH TELEMETRY BETWEEN HER IPG AND CHARGING SYSTEM. THE PT STATED THAT SHE NO LONGER HAS STIMULATION. A NEW CHARGING SYSTEM WAS SENT TO THE PT. ATTEMPTS TO OBTAIN ADD'L INFO REGARDING THE PT'S CONDITION AND/OR DEVICE STATUS WERE UNSUCCESSFUL. ACCORDING TO THE MFR'S DEVICE REGISTRATION SYSTEM, THE IPG REMAINS IMPLANTED. NO FURTHER PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON RECHARGEABLE IPG | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST JUDE NEDICAL - NEUROMODULATION | 3716 | 114647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SCS LEAD: MODEL: 3186| IMPLANTED: |