FDA Adverse Event
Malfunction
Summary report: N
EON IMPLANTABLE PULSE GENERATOR
MDR report key: 2081515
·
Received April 19, 2011
Report
- Report Number
- 1627487-2011-02455
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE LOT AND SERIAL NUMBERS FOR THE IPG WERE NOT PROVIDED. 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
THE PATIENT RECEIVED AN SCS SYSTEM, INCLUDING AN IPG. THE PATIENT REPORTED EXPERIENCING A "VIBRATING" SENSATION WHEN SHE USES HER SCS THERAPIES. ACCORDING TO THE PATIENT, THE SENSATION ORIGINATES AT THE IPG POCKET AND CAUSES MILD DISCOMFORT. THE PATIENT IS WORKING CLOSELY WITH HER PHYSICIAN TO DETERMINE THE CAUSE AND NEXT CAUSE OF ACTION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON IMPLANTABLE PULSE GENERATOR | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |