FDA Adverse Event
Injury
Summary report: N
EON 16 - CHANNEL RECHARGEABLE IPG
MDR report key: 2237051
·
Received August 25, 2011
Report
- Report Number
- 1627487-2011-07134
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- July 29, 2011
- Report Date
- July 29, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- 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 OFT HE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2006. IT WAS REPORTED ON (B)(6) 2011 THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. THE PATIENT ALSO REPORTED HAVING SOME PROBLEMS LOCATING THE IPG WITH THE CHARGER FROM TIME TO TIME. A NEW IPG WAS IMPLANTED AND STIMULATION WAS CAPTURED POST-OPERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON 16 - CHANNEL RECHARGEABLE IPG | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 56158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other| R | IMPLANT DATE:| SCS LEAD, MODEL 3186 |