RESTORE ULTRA
Report
- Report Number
- 3007566237-2014-03066
- Event Type
- Injury
- Date Received
- October 22, 2014
- Report Date
- October 2, 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
- SC, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3550-39, LOT# N230575, PRODUCT TYPE: ACCESSORY. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 39565-65, SERIAL# (B)(6), PRODUCT TYPE: LEAD. (B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
IT WAS REPORTED THAT IN THE PAST THE PATIENT'S STIMULATOR HAD "SHORTED" AND SHE HAD SURGERY. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THIS EVENT. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE SURGERY THAT WAS PREVIOUSLY REPORTED DID NOT OCCUR. THE PATIENT DID NOT HAVE SURGERY, ONLY REPROGRAMMING IN THE OFFICE. IT WAS CLARIFIED THAT THE COMMENT MADE REGARDING "SHORTENING" WAS REFERRING TO WHEN SHE WAS REPROGRAMMED EARLIER THIS SPRING TO ASSIST WITH HER HEADACHES. THE PATIENT HAD AN INCREASE IN HEADACHES STARTING ABOUT 7 MONTHS AGO, AND ALSO CHRONIC POST-SURGICAL PAIN WITH INTERMITTENT EXACERBATIONS. THE PATIENT WAS ADJUSTED WHEN THE SYMPTOMS BEGAN, AND THE HEADACHES STILL HAD NOT IMPROVED. THE PATIENT HAD ADJUSTMENTS TO MEDICATION AND THE STIMULATOR AND BOTH HAD NOT HELPED. THE PROGRAMMING SETTINGS HAD BEEN MAXED OUT. IT WAS NOTED THAT THE DEVICE WAS WORKING PROPERLY. IMPEDANCES WERE ALL WITHIN NORMAL LIMITS AND THE BATTERY WAS CHARGED AND FUNCTIONING PROPERLY. THERE WERE NO INDICATIONS OF DEVICE ISSUES. THE PATIENT WAS TOLD TO FOLLOW-UP WITH THE HCP, AS THIS WAS AN OFF LABEL USE OF THE DEVICE. A MANUFACTURING REPRESENTATIVE WAS PRESENT AT THE (B)(6) 2014 APPOINTMENT TO ADJUST SETTINGS. THERE WAS A RETURN OF HER HEADACHES. DUE TO THE PLACEMENT OF THE LEADS, THE PATIENT WOULD NOT FEEL STIMULATION LIKE A TRADITIONAL SPINAL CORD STIMULATOR (SCS) PATIENT WOULD. THE CAUSE OF THE EVENT WAS UNKNOWN. PROGRAMMING WAS PERFORMED ON (B)(6) 2014 TO NARROW THE ON/OFF INTERVAL, THE RESULTS WERE PENDING. AT THAT APPOINTMENT THE "PARAMETERS", WHICH WAS CLARIFIED TO BE PULSE WIDTH, WERE SHORTENED TO HELP WITH COVERAGE. THEY SET IT TO 4V, WHICH WAS THE HIGHEST THEY WERE GOING TO SET HER DUE TO LEAD PLACEMENT, AND THEY CHANGED HER CYCLING TO ON FOR 20 MINUTES AND OFF FOR 5 MINUTES. DUE TO THIS THEY TOLD HER TO EXPECT TO HAVE TO RECHARGE HER DEVICE MORE, WHICH SHE HAD. THE PATIENT STILL HAD ISSUES WITH THE HEADACHES AND HAD ALSO STARTED PHYSICAL THERAPY AND BOTOX INJECTIONS, BUT IT DID NOT SEEM TO BE HELPING MUCH. SHE WAS GOING TO SEE HER HCP AGAIN FOR ANOTHER REPROGRAMMING SESSION, BUT NO APPOINTMENT WAS SET AT THIS TIME. SINCE THEY COULDN'T CHANGE PARAMETERS ANY FURTHER THE NEXT STEP WOULD BE TO TRY A DIFFERENT LEAD PLACEMENT. IT WAS NOTED THAT THE PATIENT'S PAIN WAS MOST LIKELY DUE TO HER BRAIN TUMOR GROWING IN SIZE AND THEY WANTED TO DO AN MRI SINCE THE CT SCAN HAD NOT BEEN AS DETAILED AS THE PHYSICIANS WOULD HAVE LIKED. THE BRAIN TUMOR WAS THE REASON SHE WAS GETTING THE HEADACHES AND THE REASON SHE WAS IMPLANTED WITH THE SCS SYSTEM. THE PATIENT HAD NO INJURY AND DID NOT REQUIRE HOSPITALIZATION. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672473 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00041 YR | Required Intervention |