SURESCAN
Report
- Report Number
- 3004209178-2014-11810
- Event Type
- Injury
- Date Received
- June 19, 2014
- Report Date
- May 27, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- 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 PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37791, SERIAL# UNKNOWN, PRODUCT TYPE RECHARGER; PRODUCT ID NEU_RECHARGER_ACC, PRODUCT TYPE RECHARGER. (B)(4).
(B)(4).
A COUPLING PROBLEM WAS REPORTED. AN INFORMATION REQUEST WAS MADE REGARDING THE RECHARGER. THE PATIENT NEEDED HELP WITH RECHARGING. THE PATIENT CANNOT GET A GOOD CONNECTION BETWEEN THE PATIENT AND RECHARGER TO CHARGE THE INS. THE PATIENT WAS NOT ABLE TO GET COUPLING BOXES. TWO WAS A GOOD DEAL LAST NIGHT HAVING 4 BOXES AFTER LAYING ON THE ANTENNA FOR OVER 2 HOURS. IT WAS ENDLESS AND HAS UPSET THE PATIENT . THE PATIENT WAS NOT PREPARED FOR EVERYTHING THAT GOES INTO THE RECHARGER. THE PATIENT SPOKE WITH THE COMPANY REPRESENTATIVES AND DOCTOR, SHE UNDERSTOOD THE SURGERY AND HAD TO GO THROUGH THE PSYCHOLOGICAL THING JUST TO QUALIFY THAT THE HER EXPECTATIONS WERE REASONABLE. THE PATIENT DID NOT USE THE BELT AND THOUGHT THE BELT WAS POORLY DESIGNED. THE PATIENT WAS JUST IMPLANTED A WEEK AGO. THE ISSUE RIGHT NOW WAS THAT SHE HAD LET THE CHARGE GO ALL THE WAY DOWN. THE PATIENT WAS SENT HOME AND DID NOT REALLY KNOW HOW TO RECHARGE UNTIL HAVING THE FIRST MEETING WITH THE DOCTOR AND COMPANY REPRESENTATIVE WHICH WAS YESTERDAY. AFTER TAKING THE BANDAGE OFF IT WAS VERY HARD TO FIND THE RIGHT SPOT AND THE COMPANY REPRESENTATIVE EVEN MARKED WHERE IT WAS. THE PATIENT LAID THERE FOR OVER 2 HOURS AND WAS APPROACHING ABOUT 50%. WHEN THE PATIENT PUTS THE BELT ON IT POPS RIGHT OFF. WHILE MAKING THE REPORT THE PATIENT TRIED USING THE BELT, SHE DID NOT HAVE ANY COUPLING BOXES THAT WERE SHADED IN. THE PATIENT WAS HOLDING THE BELT ON HER. THE PATIENT TRIED TO MOVE THE ANTENNA AROUND A FEW TIMES AND WAS ABLE TO GET A COUPLE SHADED BOXES BUT THEN LOST THEM RIGHT AWAY. THE ANTENNA LOCATE FEATURE WAS PERFORMED AND GOT THE NUMBER 40, THE PATIENT COULD ONLY GET TO NUMBER 42. THERE WAS SOME SWELLING AROUND THE IMPLANT AND THE PATIENT HAS A BAND-AID ON THE AREA. THE PATIENT THOUGHT SHE HAD A VERY REALISTIC EXPECTATION. THE PATIENT DID UNDERSTAND THE SURGERY AND THE GENERAL IDEA OF THE TRIAL BUT SHE WAS NOT CLEAR THAT THERE WOULD BE ALL OF THIS EQUIPMENT AND THERE MAY BE AN ISSUE RECHARGING, IT WAS FRUSTRATING FOR HER. THE PATIENT KNEW SHE WOULD HAVE TO BE CAREFUL MOVING BUT THE WAY SHE UNDERSTOOD IT SHE SHOULD NOT EXTEND HERSELF AT ALL, 6 WEEKS WAS A LONG TIME. IT WAS NOTED THAT THE IMPLANT WAS ON HER LEFT HIP. THE PATIENT HAS ONLY BEEN OUT OF THE HOUSE A COUPLE TIMES. THE PATIENT WAS GOING TO TRY AN ACE BANDAGE TO TRY ON THE RECHARGER AND MAY TRY A GIRDLE NEXT TIME SHE RECHARGES. THE PATIENT HAS ANOTHER APPOINTMENT WITH THE DOCTOR IN 3 WEEKS. THE COMPANY REPRESENTATIVE REPORTED A FEW DAYS LATER THAT THE RECHARGING FREQUENCY MATCHED THE PATIENT¿S SETTINGS. THE PATIENT WAS TRAINED AND WAS ABLE TO DEMONSTRATED EFFECTIVE RECHARGING. NO DIAGNOSTICS WERE PERFORMED. NO MALFUNCTIONS OR CAUSE OF ISSUE WAS DETERMINED. NO INTERVENTIONS WERE TAKEN OR PLANNED. THE PATIENT WAS ABLE TO RECHARGE EFFECTIVELY. TEN DAYS LATER THE PATIENT REPORTED TO HAVING PAIN. SINCE IMPLANT THE PATIENT WAS HAVING A LOT OF ISSUES CHARGING THE INS. IT WAS SUGGESTED THAT THE PATIENT ORDER A NEW RECHARGER ANTENNA. THE BELT WAS USELESS AND DOES NOT STAY IN PLACE. THE ACE BANDAGE HELPS TO KEEP IT ON AND DOES NOT MOVE AS MUCH. THE PATIENT HAS NEVER BEEN ABLE TO CHARGE FULLY AND IT LASTS ABOUT A DAY. THESE PROBLEMS STARTED SINCE IMPLANT. THE MOST COUPLING BOXES SHE HAS GOTTEN WAS 4 BOXES/4 BARS, NEVER GETS ALL OF THE BARS. THE PATIENT HAS AN APPOINTMENT A WEEK FROM TOMORROW, (B)(6). THE PATIENT WAS WORKING TOWARDS 25% CHARGED. WHEN THE PATIENT DID IT SATURDAY EVENING FOR A WHILE IT WAS 4 BARS AND SHE SPENT A LOT OF HOURS IT APPEARED TO BE 50% CHARGED AND WORKING TOWARDS 75%. IT WOULD HAVE LASTED MORE THAN ONE DAY, DURING THE NIGHT IT RUNS OUT. AT NIGHT WAS WHEN THE PATIENT SEEMS TO HAVE MORE PAIN, SHE WAKES UP AND IS IN MORE PAIN. PART OF THE TIME THE PATIENT HAS TO GO WITH NO RELIEF. WHEN STARTED THE CHARGE IT WAS RUN DOWN. THE PATIENT DID TRY IN THE BEDROOM AND HAS NOT REALLY TRIED TO CHARGE ANYWHERE ELSE. A NEW ANTENNA WAS ORDERED FOR THE PATIENT. IT WAS ADDITIONALLY REPORTED THAT THE RECHARGER ANTENNA WAS DAMAGED. ANOMALY APPEARS TO HAVE OCCURRED THROUGH PRODUCT USE. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S THERAPY WAS NOT WORKING AS EXPECTED AND WANTED TO MEET WITH A MANUFACTURING REPRESENTATIVE FOR A DEVICE CHECK AND/OR PROGRAMMING. IT WAS NOTED THAT THE PATIENT WAS STILL HAVING TROUBLE CHARGING. IT WAS NOTED THAT IT WAS A CONSTANT ISSUE AND THAT NOTHING HAD CHANGED. THE REPORTER NOTED THAT FOR TWO MONTHS, THE PATIENT WAS IN THE HEALTH CARE PROFESSIONAL'S OFFICE EVERY WEEK WITH ONE OF THE MANUFACTURING REPRESENTATIVES. THE PATIENT STATED THAT SHE SAW THE HEALTH CARE PROFESSIONAL A COUPLE OF WEEKS PRIOR TO THE REPORT AND TALKED ABOUT POSSIBLY REPLACING THE CURRENT IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS FURTHER REPORTED THAT THE PATIENT HAS HAD PROBLEMS CHARGING SINCE (B)(6) 2014. THE PATIENT COULD NOT GET PAST 1/2 FULL AND HAD TO SIT FOR HOURS AND HOURS AND COULD NOT KEEP ALL 8 BARS FOR COUPLING. IT WENT FROM 8 TO 4 TO 6 ETC AND THE PATIENT WAS CONSTANTLY MOVING AND USING THE ANTENNA LOCATE (AL) FEATURE. IT WAS NOTED THAT THE INS HAD NEVER GONE PAST 50% CHARGED PER THE PATIENT. THE PATIENT TRIED TO MOVE THE RECHARGER ANTENNA AND RESET IT. THE PATIENT HAD A NEW RECHARGER SENT TO HER A FEW WEEKS AFTER IMPLANT. THE REPORTER NOTED THAT THE INS BATTERY MAY BE TILTED OR IT MAY BE IMPLANTED DEEPER. THE MANUFACTURING REPRESENTATIVE WAS ABLE TO GET ALL 8 COUPLING BARS BUT THEY WENT AWAY WITHOUT THE PATIENT MOVING. IT WAS UNKNOWN IF THE DEVICE WAS SUTURED DOWN. THE REPORTER NOTED THAT THE PATIENT WANTED TO TRAVEL AND FELT TETHERED TO THE DEVICE. IT WAS IMPLANTED IN THE LEFT AREA AT THE CREST LEVEL AND NOT THE BUTTOCK. IT WAS FURTHER REPORTED THAT THE PATIENT PROGRAMMER AND CHARGING SYSTEM WERE WORKING. THE PATIENT WAS HAVING DIFFICULTY GETTING THE CHARGE PAST 4-5 BARS AND THE CHARGING WAS TAKING LONGER THAN THE PATIENT EXPECTED. IT WAS DISCUSSED WITH THE HEALTH CARE PROFESSIONAL OF POSSIBLY REVISING THE POCKET AND BRINGING THE BATTERY CLOSER TO THE SKIN OR REPLACING WITH A NON-RECHARGEABLE BATTERY. THE PATIENT WAS STILL RECEIVING THERAPEUTIC STIMULATION. IT WAS NOTED THAT NO DECISION WAS MADE YET AS THE PATIENT WOULD NEED TIME TO THINK ABOUT THE OPTIONS. IT WAS LATER REPORTED THAT THE PATIENT WOULD MOST LIKELY MOVE FORWARD WITH A POCKET REVISION FOR THE BATTERY IN ORDER TO EASE HER TROUBLES OF RECHARGING. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
A MONTH LATER, THE PATIENT REPORTED THAT SHE HAS HAD A TERRIBLE TIME WITH CHARGING HER INS SINCE IMPLANT, IT WAS ANNOYING. NO MATTER WHAT THE PATIENT TRIED IT DID NOT APPEAR TO MAKE ANY DIFFERENCE. NO MATTER WHAT KINDS OF AID THE PATIENT USED SHE WAS NOT ABLE TO GET ENOUGH BARS, WOULD NEVER GET MORE THAN 6 BARS. THE PATIENT WAS CHARGING THE INS ALMOST EVERY NIGHT. THE PATIENT SITS EVERY NIGHT FOR 2 HOURS OR MORE TRYING NOT TO MOVE AN INCH, SHE WOULD ONLY GET 4 BARS AND THEN IT WOULD GO DOWN TO 2 BARS. THE PATIENT COULD NEVER GET A GOOD CHARGE, NEVER GET TO 100% CHARGE. ONE NIGHT THE PATIENT WAS ABLE TO GET 4-6 BARS AND GOT THE INS CHARGED TO 50%, SAW IT WORKING TOWARDS 75%. THE COMPANY REPRESENTATIVE ATTEMPTED TO CHANGE THINGS AROUND, NARROWED THE WIDTH HOPING IT WOULD CHARGE FASTER. THE PATIENT WAS REPROGRAMMED LAST WEEK. AN 8840 (CLINICIAN PROGRAMMER) WAS USED EACH TIME AT THE HEALTH CARE PROVIDER¿S (HCP) OFFICE. AN X-RAY WAS ALSO DONE AND SAID THE LEADS WERE FINE. THE PATIENT HAS BEEN AT THE HCP¿S OFFICE EVERY SINGLE WEEK SINCE IMPLANT. THE PATIENT WORKS WITH DIFFERENT COMPANY REPRESENTATIVES. CHARGING THE INS WAS A TERRIBLE PROBLEM TO THE PATIENT. THE INS WAS OUT OF CHARGE AND THE PATIENT NEEDS TO RECHARGE IT. THE ANTENNA WOULD MOVE AND GO OFF AND THE BELT WOULD COME OFF WHEN THE PATIENT WAS TRYING TO USE THE BELT. THE BELT THE PATIENT MADE FOR THE INS DID NOT WORK WELL, ANTENNA WOULD NOT STAY IN PLACE. THE PATIENT TRIED A RUBBER BELT BUT SHE COULD NOT GET A DECENT CHARGE. THE PATIENT ALSO TRIED ADHESIVE DISKS, THEY WORKED BETTER THAN THE BELT BUT STILL COULD NOT HOLD IT TO GET THE INS CHARGED. WHEN THE HCP HEARD THAT THE PATIENT HAS TRIED AND DONE EVERYTHING IT WAS REALIZED THAT IT WAS NOT THE PATIENT AND THAT THERE MIGHT BE A POSSIBILITY THAT THERE WAS SOMETHING WRONG WITH THE INS. THE HCP SAID IT MIGHT BE A DEFECTIVE BATTERY.
THE ANTENNA WAS NOT RETURNED TO THE DEVICE MANUFACTURER. IT WAS REPORTED TWO WEEKS LATER THAT THE PATIENT STILL HAS CONCERNS REGARDING HER DEVICE OR THERAPY BUT WAS WORKING WITH HER DOCTOR OR COMPANY REPRESENTATIVE. AN APPOINTMENT DATE OF (B)(6) 2014 WAS NOTED. THE PATIENT CANNOT GET THE DEVICE FULLY CHARGED. THE PATIENT THOUGHT THE BELT AND ANTENNA WERE AWKWARD AND UNCOMFORTABLE TO USE. THE BELT DOES NOT STAY FASTENED WHEN YOU FINALLY GET IT IN PLACE. PERHAPS THE CLASP SHOULD HOOK FROM UNDERNEATH SO THAT THE TENSION COULD KEEP IT TOGETHER. A FEW DAYS LATER IT WAS CLARIFIED THAT THE BELT CLOSURE UNFASTENS EVERY TIME THE PATIENT MOVES. THE PATIENT MADE HER OWN BELT TO SOLVE THE PROBLEM. IT WAS STILL DIFFICULT TO CHARGE TO 100%, THE ANTENNA WAS REPLACED. NO MALFUNCTIONS WERE SEEN. THE PATIENT WAS CHARGING ALMOST EVERY DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360643 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Required Intervention |