RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-20753
- Event Type
- Injury
- Date Received
- November 13, 2013
- Report Date
- October 23, 2013
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
PRODUCT ID: 97791, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 97791, PRODUCT TYPE: ACCESSORY.
(B)(4).
.
ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SERIAL # (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE LEADS (SERIAL # (B)(4) AND SERIAL # (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE STIMULATION ANCHORS FOUND NO ANOMALY. (B)(4)
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4).
ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
IT WAS REPORTED, THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. IT WAS NOTED, THE PATIENT WAS IN A STANDING POSITION WHEN THEY FELT A ZING DOWN THEIR LEG. IT WAS FURTHER NOTED THAT THIS CAUSED THE PATIENT TO FALL RESULTING IN A BROKEN LEG AND RIB. THE REPORTER STATED THEY BECAME AWARE OF THE EVENT WHEN THE PATIENT WAS HAVING THEIR NECK EXAMINED BY THEIR HEALTHCARE PROFESSIONAL. IT WAS NOTED THE MANUFACTURING REPRESENTATIVE WOULD BE MEETING WITH THE PATIENT TOMORROW TO GET MORE INFORMATION. THE REPORTER STATED, THE PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF AND WAS AFRAID TO TURN THE INS BACK ON. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STANDING STILL ON THEIR DECK WHEN THEY GOT A SPONTANEOUS SURGE NOT RELATED TO POSITIONAL CHANGE. IT WAS NOTED THAT THIS CAUSED THE PATIENT TO FALL AND BREAK THEIR LEG IN THREE PLACES. IT WAS FURTHER NOTED THAT THERE WERE NO SOURCES OF ELECTROMAGNETIC INTERFERENCE NEAR THE PATIENT¿S DECK. THE REPORTER STATED THERE WAS A POWER POLE WITHIN 6-8 FEET OF THE DECK, BUT NO WIRES OR ANYTHING NEARBY. IT WAS NOTED, THE INS WAS DEAD AND THE PATIENT WAS IN DISCHARGE THE LAST TIME THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT. IT WAS FURTHER NOTED, THE PATIENT HAD NOT HAD STIMULATION FOR SIX WEEKS SINCE THE SURGE. THE REPORTER STATED THEY TURNED STIMULATION BACK ON TODAY AND SET ¿UPRIGHT¿ AND ¿UPRIGHT AND MOBILE¿ TO 0.0V. IT WAS NOTED, THE PATIENT WAS SCARED TO HAVE THE INS ON WHEN STANDING UP. IT WAS FURTHER NOTED THAT BOTH OF THE PATIENT¿S PROGRAMS WERE AT 0.0V. THE REPORTER STATED THAT LYING AMPLITUDES WERE 2.8 V AND THE PREVIOUS UPRIGHT VOLTAGES WERE 3.8V. THE REPORTER FURTHER STATED THEY DO NOT THINK ADAPTIVE STIMULATION VOLTAGE CHANGES WERE RELATED TO THE SURGE THAT THE PATIENT FELT SIX WEEKS AGO. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE CHANGED THE TRANSITION TIME FROM 20 SEC TO 0 SEC FOR LYING TO UPRIGHT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS OVERSTIMULATION. IT WAS NOTED THAT THE PATIENT FELT A STRONG SHOCK, FELL AND BROKE THEIR LEG. SURGICAL INTERVENTION OCCURRED INCLUDING EXPLANT OF THE INS AND TWO LEADS. IT WAS NOTED THAT THERE WAS A REPLACEMENT WITH THE PRODUCT OF A DIFFERENT MANUFACTURER. THE DATE OF THE EXPLANT AND REPLACEMENT WAS 2014 (B)(6). THE PATIENT DID NOT REQUIRE HOSPITALIZATION AS A RESULT OF THE EVENT. THE CAUSE OF THE ISSUE WAS UNKNOWN. IT WAS NOT KNOWN IF THE EVENT WAS DUE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) OR THE LEAD/EXTENSION. THE PATIENT OUTCOME WAS NON-SERIOUS INJURY OR ILLNESS.
THE PATIENT¿S HEALTH CARE PROVIDER (HCP) REPORTED ON (B)(6) 2014 THAT THE PATIENT¿S DEVICE SYSTEM WAS BEING EXPLANTED TODAY. THE REASON FOR EXPLANT WAS THAT THE PATIENT WOULD JUST BE STANDING THERE DOING FINE AND THEIR STIMULATION WOULD GO HAYWIRE, THEN SHOCK THE CRAP OUT OF THEM. THE SHOCKING WAS ENOUGH THAT IT WOULD TAKE THE PATIENT TO THEIR KNEES. LEAD PLACEMENT UNDER X-RAY SHOWED EVERYTHING WAS FINE. THE DEVICE CAUSED THE PATIENT TO FALL AND BREAK THEIR LEG. THE SHOCKING EVENTS CONTINUED TO OCCUR AND THAT WAS WHY DEVICE EXPLANTED WAS HAPPENING TODAY. UPON EXPLANT, THE PATIENT WAS GOING TO BE IMPLANTED WITH A DIFFERENT MANUFACTURERS SYSTEM. THE DOCTOR WAS GOING TO HAVE THE DEVICE RETURNED TO THE DEVICE MANUFACTURER.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION WHICH CAUSED THE PATIENT TO FALL AND BREAK THE LEAD. PER THE CALLER, THE PATIENT WAS GOING TO HAVE THE SYSTEM OR LEAD EXPLANTED THE WEEK OF (B)(6) 2014 OR THE FOLLOWING WEEK. THE CALLER HEARD THE REPORT FORM A HEALTHCARE PROFESSIONAL (HCP) DURING A VISITS WITH THE MANUFACTURER REPRESENTATIVE TO THE HCP'S OFFICE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NOTED PERIODIC OVERSTIMULATION AND THAT IT "JUST TURNED UP ON ITS OWN." THE PATIENT WAS NOT IN A CLINICAL STUDY. THE DEVICE WAS NOT REPLACED WITH A PRODUCT FROM THE MANUFACTURER. THE THERAPY WAS PAIN.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN X-RAY SHOWED THAT ONE LEAD HAD MIGRATED. IT WAS NOTED THE IMPEDANCE TESTING WAS DONE AND IMPEDANCES WERE NORMAL. IT WAS FURTHER NOTED THE PATIENT WAS REPROGRAMMED TO TAKE THE PATIENT OUT OF ADAPTIVE STIMULATION MODE. THE REPORTER STATED THE PATIENT REPORTED THE"ZINGS" STILL HAPPENED INTERMITTENTLY WITHOUT WARNING. THE REPORTER FURTHER STATED THEY COULD NOT DETERMINE ANY MALFUNCTIONS. IT WAS NOTED THE PATIENT STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) SUDDENLY INCREASED IN STRENGTH WHILE THEY WERE IN A STATIC POSITION. IT WAS NOTED THAT NO INTERVENTIONS HAD BEEN PERFORMED, BUT THE PATIENT WOULD LIKE THEIR LEAD REVISED AND THE INS REPLACED. IT WAS FURTHER NOTED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY, BUT THEY ONLY USE STIMULATION WHILE IN THE LYING POSITION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT MAY BE A FEW MONTHS BEFORE THE REVISION IS DONE.
IT WAS FURTHER REPORTED THAT THE INS WAS EXPLANTED AND RETURNED. THE LEADS WITH SERIAL NUMBERS (B)(4) WERE ALSO EXPLANTED AND RETURNED. THERE WERE ALSO TWO ANCHORS WITH UNKNOWN SERIAL NUMBERS THAT WERE EXPLANTED AND RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 587866 | 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 |