RESTORE SENSOR
Report
- Report Number
- 3004209178-2014-08492
- Event Type
- Injury
- Date Received
- May 5, 2014
- Report Date
- April 11, 2014
- 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
- IL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION. ON EITHER (B)(6) THE PATIENT LEANED AGAINST A METAL STRIP ON THEIR TOILET AND FELT A LITTLE SHOCK. THEY DID THIS TWICE. THE PATIENT DID NOT FEEL ANY CHANGE IN THERAPY. THE PATIENT HAD BRONCHITIS AND RESPIRATORY INFECTIONS. THE PATIENT HAD BEEN ON ANTIBIOTICS SINCE (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS FURTHER REPORTED THAT AT ABOUT 11:30 PM ON (B)(6) THE PATIENT STOPPED FEELING STIMULATION AND THEY HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HOOKED UP THEIR RECHARGER AND STARTED CHARGING THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THEY WERE GOING TO WAIT UNTIL IT WAS ¼ CHARGED BEFORE TURNING THEIR STIMULATION BACK ON. THE PATIENT HAD RODS FROM THEIR NECK DOWN AND A MONTH AND A HALF PRIOR TO THE REPORT THEY WERE IN THEIR CAR AND TWISTED TO PICK SOMETHING UP AND SOMETHING POPPED IN THEIR BACK WHERE THEIR INS WAS. THIS ¿DIDN¿T TOUCH THE PAIN.¿ THE PATIENT WENT TO THEIR DOCTOR AND HAD A CAT SCAN AND AN X-RAY 1-3 MONTHS PRIOR TO THE REPORT. THE PATIENT HAD BEEN GETTING LITTLE SHOCKS IN THEIR HIP FROM WHERE THE STIMULATOR WAS GIVING SHOCKS. THE PATIENT WAS AT THE SENIOR OLYMPICS THE NIGHT PRIOR TO THE REPORT AND EVERY STEP ON THEIR RIGHT LEG THEY HAD A PROBLEM. THE PATIENT THOUGHT THEY ALSO HAD A PROBLEM WITH A MUSCLE OR TENDON BUT EVERY STEP THEIR STIMULATION SHOCKED THEM AT THE IMPLANT SITE. THE PATIENT DIDN¿T THINK THEY WERE GOING TO MAKE IT SINCE THEY WERE A WAYS AWAY FROM THE BATHROOM AND THEY HAD TO STOP SEVERAL TIMES TO LEAN AGAINST A POST. THE PATIENT DID A LOT OF WALKING THE NIGHT PRIOR TO THE REPORT AND ON THE DAY OF THE REPORT. THE PATIENT HAD HAD CHRONIC BRONCHITIS SINCE THE DECEMBER PRIOR TO THE REPORT AND HAD BEEN ON ANTIBIOTICS. THE PATIENT GOT A URINARY TRACT INFECTION AND THEIR DOCTOR PUT THEM ON MEDICINE AND WANTED TO TEST TO PUT THE PATIENT TO SLEEP SINCE THE PATIENT HAD BLOOD IN THEIR URINE. THE PATIENT HAD TO CANCEL THIS TEST SINCE THEY COULD NOT GET OVER THE BRONCHITIS. THE PATIENT COULD NOT REMEMBER WHEN THEY HAD THE URINARY TRACT INFECTION BECAUSE THEY HAD A BUNCH OF DEAD BLOOD VESSELS IN THEIR BRAIN THAT AFFECTED THEIR MEMORY. THE PATIENT THOUGHT THE URINARY TRACT INFECTION WAS ABOUT A MONTH PRIOR TO THE REPORT. THE PATIENT HAD SEEN THEIR DOCTOR A COUPLE OF DAYS PRIOR TO THE REPORT AND THAT¿S WHEN THEY ORDERED THE CAT SCAN AND X-RAY. THE PATIENT¿S DOCTOR SAID EVERYTHING LOOKED FINE AND IN PLACE. THE PATIENT HAD MORE PAIN BUT NOT THE HORRIBLE PAIN LIKE THEY¿D HAD IN THE PAST. IT WAS FURTHER REPORTED THAT AFTER THE PATIENT TURNED THEIR STIMULATION BACK ON WITH THEIR RECHARGER THEY WERE ABLE TO FEEL STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267496 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |