SYNERGY
Report
- Report Number
- 3004209178-2013-00009
- Event Type
- Injury
- Date Received
- January 2, 2013
- Report Date
- December 10, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID, 7496-51 LOT# SERIAL# (B)(4), IMPLANTED: 1996 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7435 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3982 LOT# SERIAL# (B)(4), IMPLANTED: 1996 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3550-09 LOT# N220024, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).
FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2013 AT WHICH TIME THE IMPLANTABLE NEUROSTIMULATOR POCKET WAS MOVED FROM THEIR CHEST WALL TO THE ABDOMEN SO IT WAS NOT SO SUPERFICIAL. FOLLOWING THE SURGERY, THE PATIENT WAS REPORTED AS RECEIVING EFFECTIVE THERAPY. THE PATIENT HAD A FOLLOW UP APPOINTMENT SCHEDULED FOR (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS CURRENTLY BEING TREATED ON ORAL MEDICATIONS. THE REPORTER STATED THAT THE PATIENT'S SURGERY DATE HAD BEEN PUSHED BACK TO (B)(6)-2013. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S SURGERY WAS CANCELLED AND MOVED TO (B)(6) 2013. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED THE INFECTION SITE LOOKED '10 TIMES" BETTER AND THE NEW POCKET SITE LOOKED 'GREAT.' THE PATIENT WAS FEELING GREAT AND WAS NO LONGER ON ORAL MEDICATIONS. THE PATIENT'S NEXT APPOINTMENT WAS FOR (B)(6) 2013. THE PATIENT WAS RECEIVING 'GREAT' THERAPY, AND THERE WAS NO SIGN OF INFECTION.
IT WAS REPORTED, THERE WAS AN INFECTION. IT WAS NOTED, THE PATIENT HAD FALLEN AND GOTTEN A SCRAPE WHICH CAUSED THE INFECTION. THE PATIENT HAD BEEN PUS AT THE CHEST SITE SO THEY REMOVED THE BATTERY. THE EXTENSION AND LEAD WERE STILL IN PLACE. FOLLOW UP REPORTED. THE PATIENT WAS SCHEDULED TO HAVE THE EXTENSION AND LEAD REMOVED. IT WAS NOTED THEY WERE UNSURE IF THE FALL WAS HOW THE PATIENT GOT INFECTED, BUT IT WAS KNOWN THERE WAS SOME INCIDENT/INJURY AND WHEN THEY REMOVED THE BATTERY THERE WAS PUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BEEN SEEN THE DAY OF THIS REPORT AND THE PATIENT HAD NO INFECTION AND THEIR WOUNDS HAD HEALED GREATLY. THE OLD POCKET LOOKED NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1636 | SYNERGY | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |