SURESCAN
Report
- Report Number
- 3004209178-2014-09656
- Event Type
- Malfunction
- Date Received
- May 27, 2014
- Report Date
- May 6, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- GZB
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4)
(B)(4).
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. 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: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6)2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4)
(B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND THE IMPLANT HAD NOT WORKED SINCE IMPLANT. ALL OF THE PATIENTS JOINTS HURT, SHOULDER, KNEES , HIPS, AND THE PATIENT COULDN¿T SLEEP. THE HEALTHCARE PROVIDER (HCP) HAD DONE BLOOD WORK BUT NO TEST RESULT HAD SHOWN A CAUSE OF HIS PAIN. THE PATIENT THOUGHT IT COULD BE THE PAIN STIMULATION DEVICE CAUSING THE PAIN. THE PATIENT¿S HCP ¿GAVE UP ON HIM¿ AND DID NOT HAVE A CURRENT HCP. THE TRIAL DEVICE DID WORK FOR THE PAIN. THE PATIENT WANTED THE DEVICE REMOVED AND HIS MONEY BACK BECAUSE THERAPY NEVER WORKED FOR THE PATIENT. THE MANUFACTURER REPRESENTATIVE WOULD FOLLOW UP WITH THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THEY WANTED ASSISTANCE TO GET INTO MRI MODE BUT THEIR IMPLANT WAS DEPLETED. THE PATIENT PROGRAMMER (PP) WAS USED TO CONNECT WITH THE IMPLANT WHICH SHOWED THAT STIMULATION WAS OFF. THE PATIENT WAS GOING TO RECHARGE AND CALL BACK LATER FOR ASSISTANCE. IT WAS ORIGINALLY STATED THE MRI WAS NOT RELATED TO THE PATIENT'S DEVICE, BUT LATER THE PATIENT STATED IT WAS FOR BACK PAIN. IT WAS ADDITIONALLY REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) DIDN'T PROVIDE PAIN RELIEF TO THE PATIENT'S BACK SINCE IMPLANT, DESPITE NUMEROUS ADJUSTMENTS. THE PATIENT ALSO STATED THEY EXPERIENCED STIMULATION IN THE WRONG LOCATION SINCE IMPLANT AND A LOSS OF THERAPY WAS REPORTED. THE PATIENT CALLED BACK LATER AND WAS ABLE TO PUT THEIR DEVICE INTO MRI MODE AND TURN STIMULATION BACK ON.
IT WAS FURTHER REPORTED THAT THE PATIENTS PHYSICIAN CITED SOME PSYCHOLOGICAL AND EMOTIONAL COMORBIDITIES THAT MAY BE INTERFERING WITH EFFECTIVE TREATMENT OF HIS PAIN PATHOLOGY. THE PHYSICIAN BELIEVED THAT A REVISION OR OTHER INTERVENTION DOES NOT OFFER THIS PATIENT SIGNIFICANT HOPE OF AN IMPROVED OUTCOME.
ALMOST TWO MONTHS LATER THE FIRST OVERDISCHARGE WAS CONFIRMED. A PHYSICIAN MODE RECHARGE (PMR) SUCCESSFULLY RESET THE DEVICE. THE POWER ON RESET (POR) WAS SUCCESSFULLY CLEARED. THE PATIENT WAS NOT HAPPY WITH HIS THERAPY AND STOPPED USING THE STIMULATION MONTHS AGO. THE PATIENT REFUSED TO BRING IT BACK TO LIFE. THE PATIENT WAS ON A LOT OF MEDICATION DUE TO AN UNRELATED DEVICE ISSUE, HE HAS SINCE GOTTEN OFF ALL MEDICATIONS AND HAVE SEEN A NEW PHYSICIAN. THE PATIENT WAS GOING TO START PHYSICAL THERAPY. IT SEEMED TO BE A NEW AND POSITIVE MIND SET FOR THE PATIENT. CURRENTLY THE PATIENT WAS USING A HIGH FREQUENCY PROGRAM AND WILL BEGIN CHARGING EVERY OTHER DAY OR DAILY IF NECESSARY. THERE WAS NO FURTHER INFORMATION TO PROVIDE AT THIS TIME.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD SOME SUCCESS WITH THE TRIAL BUT HAD LIMITED TO NO RELIEF WITH THE ACTUAL IMPLANT. THERE HAD BEEN 6 ATTEMPTS, TO THE PATIENT'S KNOWLEDGE, TO ADJUST THE DEVICE WITH NO RESULTS. THEREFORE, THE PATIENT HAD NOT BEEN ABLE TO BENEFIT FROM IT. THE PATIENT WAS WONDERING IN THIS TYPE OF SITUATION WHAT THE NEXT COURSE OF ACTION WAS. THE UNIT DID NOT WORK. THEY TRIED TO ADJUST IT DIFFERENT TIMES WITH NO RESULTS.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HADN¿T BEEN USING THE IMPLANTABLE NEUROSTIMULATOR (INS) MUCH AND THEN COULDN¿T GET IT TO CHARGE AT THE TIME OF THE REPORT. IT WAS ¿QUITE A WHILE AGO¿ WHEN THE PATIENT LAST CHARGED. THE PATIENT TRIED TO START CHARGING THE DAY PRIOR. THE PATIENT COULD NEVER GET IT ADJUSTED RIGHT SO THAT¿S WHY THEY STOPPED USING THE INS. THE PATIENT WAS ON MEDICATIONS BUT THEN THEY WANTED TO GET OFF THE MEDICATIONS AND START USING THE INS AGAIN. AN INS OVERDISCHARGE WAS SUSPECTED. THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. THE PATIENT COULD NOT COMMUNICATE WITH THEIR DEVICE.
IT WAS REPORTED THAT THE STIMULATOR WAS NOT PROVIDING SIGNIFICANT RELIEF. IT WAS FURTHER NOTED THAT AN XRAY DEMONSTRATED SLIGHT LEAD MIGRATION. THE CAUSE WAS NOT DETERMINED. ALL OTHER TESTS WERE WITHIN NORMAL LIMITS. THE PATIENT STATED HE HAD NEVER FELT PARAESTHESIA IN HIS BACK. THE PATIENT STATED HE DIDN¿T FEEL IT DURING THE TRIAL EITHER, BUT THE TRIAL HELPED HIM. IT WAS REVIEWED WITH THE PATIENT THAT IT WAS NOT ALWAYS NECESSARY TO FEEL PARAESTHESIA TO GAIN PAIN RELIEF. THE PATIENT WAS REPROGRAMMED AND NO FURTHER ACTION WAS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310460 | SURESCAN | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | GZB | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 97714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR |