FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 4240640
·
Received November 10, 2014
Report
- Report Number
- 9614453-2014-02592
- Event Type
- Injury
- Date Received
- November 10, 2014
- Report Date
- November 5, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3487A00101, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 3487A00101, SERIAL# (B)(4), PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT COMPLAINED OF STIMULATION IN THEIR SUBCUTANEOUS TISSUE OVER THE CONNECTOR SITE INSTEAD OF THEIR NORMAL PARASTHESIAS. X-RAYS WERE DONE AND BOTH LEADS WERE FOUND TO HAVE MIGRATED COMPLETELY OUT OF THE EPIDURAL SPACE.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT¿S LEADS MIGRATED AND THEY WERE REVISED IN (B)(6) 2003. INVASIVE INTERVENTION WAS REQUIRED AND THERE WAS NO PATIENT DEATH OR INJURY. THE PATIENT¿S LEADS WERE CHANGED TO A PADDLE LEAD AND FOLLOWING THE REVISION THE PATIENT WAS DOING WELL. UNKNOWN REVISION IN (B)(6) 2003 WAS PREVIOUSLY REPORTED IN 3007566237-2014-02998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724038 | SYNERGY | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | IPG MFG SWITZERLAND | 7427AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |