EON MINI IMPLANTABLE PULSE GENERATOR
Report
- Report Number
- 1627487-2010-03013
- Event Type
- Injury
- Date Received
- October 21, 2010
- Date of Event
- September 27, 2010
- Report Date
- July 7, 2017
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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.
THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6)2010. IT WAS REPORTED THE PATIENT LOST STIMULATION AND THE DEVICE HAD STOPPED COMMUNICATING WITH THE DEVICE CHARGER. AN EXAMINATION OF THE PATIENT'S SCS SYSTEM FOUND THE IPG HAD FLIPPED WITHIN THE IPG IMPLANT POCKET. THE PHYSICIAN PLANS TO SURGICALLY REPOSITION THE DEVICE; THEREFORE, NO PRODUCTS WILL BE RETURNED. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.
FOLLOW-UP IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2017 DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. STIMULATION WAS RESTORED FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON MINI IMPLANTABLE PULSE GENERATOR | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3788 | 3131341 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |