RESTORE
Report
- Report Number
- 3004209178-2012-05541
- Event Type
- Injury
- Date Received
- July 12, 2012
- Report Date
- June 15, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377845, LOT# V001578, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 377845, LOT# V003667, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION. (B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE; PROGRAMMER, PATIENT. PRODUCT ID: 377845, LOT# V001578, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377845, LOT# V003667, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006 , PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION.
(B)(4).
(B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION AT THE DEVICE SITE WHILE RECHARGING AND AFTER STIMULATION WAS TURNED ON FOR A WHILE. THE PATIENT DID EXPERIENCE FALLS. ADDITIONALLY IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. THE PHYSICIAN NOTED THAT THE DEVICE WAS IMPLANTED TOO CLOSE TO THE HIP AND THE WIRES MAY BE TOO CLOSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
IT WAS REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. THE LAST KNOWN VISIT WAS (B)(6) 2012. THE PATIENT HAD MOVED OUT OF THE STATE AND WAS NO LONGER A PATIENT AT THE FACILITY CONTACTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
IT WAS FURTHER REPORTED THAT THE PATIENT'S DEVICE WAS SHOCKING THEM WHEN THEY WERE CHARGING THEIR DEVICE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STIMULATOR DID NOT WORK. PATIENT HAD NOT RECEIVED ASSISTANCE. THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR MANUFACTURING REPRESENTATIVE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT HAD A REPLACEMENT YET AND HAD AN APPOINTMENT WITH HIS PHYSICIAN NEXT WEEK REGARDING POSSIBLE REPLACEMENT TO A NON-RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS STATED THAT THE PATIENT SEEMED TO UNDERSTAND THE CHARGING SYSTEM BETTER NOW AND THE MANUFACTURER REPRESENTATIVE GAVE THE PATIENT STICKERS THE HELP HOLD THE CHARGING ANTENNA IN PLACE. THE PATIENT WAS REPORTEDLY DOING WELL.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STATUS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS UNKNOWN. THE MANUFACTURER REPRESENTATIVE HAD NOT HEARD BACK TO WHEN A REPLACEMENT WOULD BE SCHEDULED. NO MALFUNCTIONS WERE SEEN TO CAUSE THE RECHARGING ISSUE, PER MANUFACTURER REPRESENTATIVE. THE OUTCOME OF THE PATIENT WAS UNKNOWN.
FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD TROUBLE RECHARGING. IT WAS NOTED THAT IF TOOK THE PATIENT A LONG TIME TO GET THE IMPLANTABLE NEUROSTIMULATOR (INS) CHARGED AND REQUESTED THAT A NON-RECHARGEABLE INS MODEL BE IMPLANTED. THE PATIENT'S PHYSICIAN WAS WORKING ON THIS REQUEST. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT
ADDITIONAL INFORMATION STATED THE PATIENT HAD A LOT OF PROBLEMS WITH THE IMPLANT SITE. IT WAS NOTED THE PATIENT GOT SEVERE PAIN AT IMPLANT SITE AND IT WASN'T WORTH TURNING THE STIMULATION ON BECAUSE HE WOULD BE ¿THROWN TO THE WALL AND ON THE FLOOR WHEN IT WAS TURNED ON.¿ CALLER SAID IT WAS TORTURE TO RECHARGE, ¿IT FELT LIKE HE WAS ON FIRE.¿ THE INS CAUSED SHOCKING SENSATION AND THE PATIENT WOULD SEE THE RECHARGE AREA RED AFTER THE RECHARGE SESSION WHICH TOOK 5-6 HOURS.
ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE PATIENT HAD THE BURNING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE PAST 2 YEARS. THE PATIENT ALSO EXPERIENCED PAIN FROM THE STIMULATION DUE TO THE BURNING IN ADDITION TO THE STIMULATION WAS NO LONGER HELPING THEIR PAIN. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED THE BURNING WHILE RECHARGING THE INS AND COULD NOT HAVE THE EXTERNAL RECHARGER UNIT (WITH AND WITHOUT ANTENNA) ON THE INS FOR VERY LONG DUE TO THIS SENSATION. THE BURNING FELT LIKE IT WAS 'COMING FROM THE INSIDE OUT.' THE PATIENT HAD STATED THAT THEY HAD 'BUMPED' THE INS SITE A FEW TIMES. PRIOR TO THE BURNING SENSATION, THE PATIENT WAS REPORTED AS GETTING PAIN RELIEF FROM THE INS DEVICE. IT WAS REPORTED THAT THE PATIENT HAD NO FALLS OR SHOCKING SENSATIONS WITH THE STIMULATION THERAPY. THE PATIENT WAS SCHEDULED TO MEET WITH THE MANUFACTURER'S REPRESENTATIVE ON (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS FURTHER REPORTED THAT THE PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS REPLACED ON (B)(6) 2013 BECAUSE THE INS WAS SHOCKING HIM AND HIS SKIN WOULD TURN RED HOT WHEN HE CHARGED THE INS. IT WAS NOTED THAT THE SHOCKING OCCURRED "MOSTLY" WHEN HE WAS CHARGING BUT ALSO HAPPENED AT OTHER TIMES. IT WAS REPORTED THAT HE WOULD GET SHOCKS THAT "THREW HIM AGAINST THE WALL" AT TIMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Required Intervention |