RESTORE ADVANCED
Report
- Report Number
- 3004209178-2014-12451
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Report Date
- July 1, 2016
- 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
- ME, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE RECHARGER; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: RECHARGER. PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT :TYPE LEAD. PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SPOKE TO A MANUFACTURER REPRESENTATIVE AND THEIR PAIN WAS STILL OUT OF CONTROL.
IT WAS REPORTED THAT A ¿COUPLE WEEKS AGO¿ A PATIENT FELL ON ONE OF HIS ¿BRACES¿ AND BROKE IT. THE CALLER STATED THAT HE ¿SMACKED HIS COMPUTER.¿ IT WAS STATED THAT THE PATIENT HAD NOT BEEN ABLE TO CHARGE FOR ABOUT A MONTH. IT WAS STATED THAT THE STIMULATOR WAS THE ONE THAT WAS BROKEN. IT WAS NOTED THAT THE PATIENT REFUSED TO TROUBLESHOOT OVER THE PHONE, STATING THAT HE WANTED TO SPEAK WITH THE ¿LOCAL GIRL.¿ IT WAS NOTED THAT THE PATIENT HAS BEEN ON ¿MANY PAIN MEDICATIONS¿. IT WAS NOTED THAT THE PATIENT STATED THAT HIS MAIN DOCTOR ¿MAY HAVE RETIRED¿. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE WOULD CALL THE PATIENT TODAY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS UNABLE TO RECHARGE HIS UNIT. IT WAS STATED THAT THE PATIENT TOLD THE MANUFACTURER¿S REPRESENTATIVE (REP) THAT IT HAD BEEN ABOUT 2 MONTHS SINCE HE RECHARGED. IT WAS NOTED THAT THE REP WALKED HIM THROUGH HOW TO DO ANTENNA LOCATE TWO TIMES. IT WAS STATED THAT ON THE SECOND TIME, THE POR (POWER ON RESTART) SCREEN CAME UP. IT WAS STATED THAT THE REP ASKED THE PATIENT TO PRESS THE SPEAKER KEY ON THE RECHARGER AND THE STIMULATOR STARTED RECHARGING NORMALLY. IT WAS NOTED THAT THE REP INSTRUCTED THE PATIENT TO RECHARGE FULLY AND INSTRUCTED HIM TO CALL REP BACK IF HE HAD ANY PROBLEMS OR WAS UNABLE TO FEEL STIMULATION WHEN STIMULATION WAS TURNED ON. IT WAS STATED THAT THE REP HAS NOT HEARD BACKFROM THE PATIENT.
ADDITIONAL INFORMATION RECEIVED REPORTED DISSATISFACTION WITH THE PATIENTCURRENT HCP AND PHYSICIANS IN GENERAL IN THE AREA. THE PATIENT REPORTED THAT HE HAD A FALL THIS PAST SATURDAY, (B)(6) 2014 AND HE THOUGHT IT WAS DUE TO HIS BRACE NOT LOCKING. THE PATIENT REPORTED THAT HIS HEAD HIT THE DRESSER AND BOUNCED OFF THE FLOOR, HE HAS A LUMP ON HIS HEAD, PAIN IN NECK AND BETWEEN HIS SHOULDER, TOP OF SPINE AND HAS A HEADACHE. THE PATIENT STATED THAT HE HURT HIS SPINE AGAIN. IT WAS NOTED THAT THE PATIENT HAD PERCOSET, BUT IT WAS NOT TAKING CARE OF THE PAIN. IT WAS STATED THAT THE PATIENT DID GO TO THE HOSPITAL AND THEY GAVE HIM A SHOT THAT KILLED SOME OF THE PAIN, HOWEVER WHEN HE WOKE UP IN RECOVERY HE SAID THAT HIS HEAD WAS STILL HURTING AND THE DISCHARGING HCP WANTED TO TRANSFER HIM TO ANOTHER HOSPITAL. THE PATIENT NOTED THAT WHILE THAT WHILE HE WAS IN THE HOSPITAL THEY WERE TRYING TO BEND HIM IN HALF,HOWEVER DUE TO HIS SPINE ISSUES, THE PAIN WAS UNBEARABLE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DISCHARGED FROM HIS HCP AND THE MANUFACTURER'SREPRESENTATIVE MENTIONED ANOTHER HCP THAT THEY UNDERSTOOD WAS GOING TO TAKE OVER THE PATIENT'SCARE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HURTING. IT WAS NOTED THAT THE PATIENT HAD LEG AND SPINE PAIN IN THE NECK AND COULDN'T SLEEP. THE PATIENT ALSO MENTIONED CARPAL TUNNEL, NALE IMPLANTfiND HAVING NO PRIMARY NERVES IN BODY. THE PATIENT MENTIONED HE HAD IN THE PAST A STROKE, HEART ATTACK, ANUERYSM. THE PATIENT MENTIONED HE HAD TAKEN ZOPHYRIN MEDICATION BEFORE. THE PATIENT STATED HE RECEIVED THE PILL IN HOSPITAL, AND SAID THAT IT WAS FANTASTIC. THE PATIENT STATED THAT HIS ARMS WERE THE SIZE OF FOOTBALLS.THE PATIENT STATED THAT HE HAD NO BLOOD VESSELS LEFT.THE PATIENT STATED NOW HE WAS HAVING BELLS IN EARS.IT WAS REPORTED THAT THE PATIENT WAS FALLING ON THE CHARGING UNIT, AND THE COMPUTER WAS MAKING ME HURT.IT WAS NOTED THAT THE PATIENT KEPT RAMBLING RANDOM BITS OF INFORMATION AND THE CALL WAS ENDED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER'SREPRESENTATIVE SPOKE WITH THE PATIENT ABOUT FINDING A MANAGING HCP. IT WAS STATED THAT THE PATIENT WAS GOING TO CALL AN HCP THAT MIGHT ACCEPT HIM AS A PAIN PHYSICIAN, BUT IT WAS NOTED THAT IT WAS AT LEAST A 5 HOUR DRIVE AWAY FROM HIM.ADDITIONAL INFORMATION RECEIVED REPORTED A COMMUNICATION PROBLEM. IT WAS STATED THAT THE PATIENT WAS ABLE TO GET TO THE REGULAR CHARGING SCREEN BUT HE COULD NOT GET ANY COUPLING BOXES. IT WAS NOTED THAT THE PATIENT TRIED THE ANTENNA LOCATE FEATURE AND WAS STILL NOT GETTING ANY SHADED COUPLING BOXES EXCEPT FOR A MOMENT AND THEN THEY WENT AWAY. THE PATIENT STATED THAT WHILE DOING ANTENNA LOCATED THE PATIENT NEVER DID SEE THE SCREEN WITH THE NUMBERS.THE PATIENT STATED HE KEPT SEEING THE INS FULLY CHARGED OR RECHARGER FULLY CHARGED ICON.
A PATIENT CODE WAS REPORTED, EVENT REPORTED AS ADVERSE EVENT <(>&<)> PRODUCT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386672 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR |