RESTORE SENSOR
Report
- Report Number
- 3007566237-2014-01783
- Event Type
- Injury
- Date Received
- June 25, 2014
- Report Date
- September 4, 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
- WV, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 74002, LOT# N240205, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ADAPTER; PRODUCT ID 3998, LOT# V004644, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION; PRODUCT ID 3998, LOT# V004644, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).
(B)(4).
THE INITIAL MDR WAS FILED AS MFR REPORT # 3007566237-2014-01783. ADDITIONAL REVIEW INDICATED THE CORRECT MANUFACTURING SITE WAS SITE 3004209178.
(B)(4).
IT WAS REPORTED THAT THE PATIENT FELT THE PUMP VIBRATING AT THE PUMP SITE WHICH THE PATIENT FIRST NOTICED ¿TWO TO THREE WEEKS AGO AROUND THE SAME TIME THAT THE HEALTHCARE PROFESSIONAL (HCP) AND MANUFACTURER REPRESENTATIVE DETERMINED THERE WERE ISSUES WITH THE STIMULATION SYSTEM WIRES.¿ THE PATIENT STATED THAT HE HAD A FALL IN THE MIDDLE OF (B)(6). THE PATIENT STATED THAT THE LEFT LEG WAS WEAK AND ¿IT JUST COMPLETELY GAVE OUT ON HIM AND HE FELL FORWARDS ON HIS STOMACH AND THEN ON HIS BACK AREA.¿ THE PATIENT STATED THAT HE HAD BRUISES ON BOTH THE IMPLANTABLE NEUROSTIMULATOR (INS) AND PUMP SITE. THE PATIENT STATED THAT THE VIBRATION ¿LASTS ABOUT FOUR TO FIVE MINUTES AND THEN SHUTS OFF AND THEN HAPPENS ABOUT TWO TO THREE HOURS LATER.¿ THE PATIENT ALSO NOTED THAT ¿SOMETIMES VIBRATION GOES DOWN THE RIGHT LEG.¿ THE PATIENT REPORTED THE VIBRATION TO THE HCP ON (B)(6) 2014 AND HAD X-RAYS AND WAS TOLD THAT ¿EVERYTHING LOOKED FINE.¿ THE PATIENT STATED THAT THE CURRENT PAIN LEVEL WAS A SEVEN AND WHEN HE WAS USING BOTH STIMULATION SYSTEM AND THE PUMP HE COULD GET THE PAIN DOWN TO A FOUR. THE PATIENT HAD AN APPOINTMENT TO SEE THE HCP (B)(6) 2014. THE PATIENT WAS REDIRECTED TO THE HCP. THE SAME DAY IT WAS REPORTED BY THE PATIENT THAT HE HAD A BATTERY REPLACEMENT (B)(6) 2014. THE PATIENT STATED THAT ¿ABOUT TWO TO THREE WEEKS¿ POST IMPLANT HE EXPERIENCED SHOCKING WHEN ¿SHE¿ MOVED HIS HAND AROUND THE STOMACH AREA. IT WAS NOTED THAT THE EVENT OR SYMPTOMS OCCURRED FOLLOWING A FALL. THE PATIENT NOTED THAT HE HAD FALLEN ¿AROUND¿ (B)(6). THE PATIENT STATED THAT HE ¿GOT UP TO WALK AND HAD A WEAK LEFT LEG AND IT JUST COMPLETELY GAVE OUT ON HIM.¿ IT WAS NOTED THAT THE PATIENT FELL ON HIS STOMACH AND THEN ON HIS BACK. THE PATIENT HAD A BRUISE ON THE PUMP SITE AND SCRATCHES NEAR THE STIMULATOR SITE. THE PATIENT STATED THAT HE WENT TO THE HCP AND ¿SOMEONE FROM [THE MANUFACTURER] WAS THERE AND HE DID HAVE X-RAYS.¿ THE PATIENT STATED THAT ¿THE [MANUFACTURER] PERSON LOOKED AT X-RAYS AND SAID THERE WAS WATER POCKET BY THE STIM INCISION SITE WHERE THE CONNECTIONS WERE.¿ THE PATIENT STATED THAT AS OF (B)(6) 2014 THEY TURNED THE STIMULATION SYSTEM COMPLETELY OFF. THE PATIENT STATED THAT THE RECOMMENDATION WAS TO REPLACE THE WIRES AND BATTERY. THE PATIENT STATED THAT IT WAS ALREADY APPROVED AND HE WAS ¿JUST WAITING FOR THE SURGERY DATE.¿ THE PATIENT WONDERED IF THE STIMULATION SYSTEM COULD BE CAUSING ISSUES WITH THE PUMP. THE PATIENT WAS REDIRECTED TO THE HCP. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT. SEE REPORT # 3004209178-2014-11611 FOR THE REPORT RELATED TO THE PUMP.
IT WAS ALSO REPORTED BY THE HEALTHCARE PROFESSIONAL (HCP) THAT THE EVENT WAS ATTRIBUTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE LEAD. IT WAS ALSO NOTED THAT IF THE ISSUE WAS DUE TO THE LEAD/EXTENSION THE ISSUE WAS OTHER. IT WAS ALSO NOTED THAT IF THE EVENT WAS DUE TO THE INS THE ISSUE WAS UNKNOWN. IT WAS NOTED THAT THE CAUSE OF THE EVENT WAS DISCOMFORT FROM THE SPINAL CORD STIMULATION (SCS) LEAD. IT WAS NOTED THAT THERE WAS POSSIBLY MIGRATION FROM ACTIVITY. IT WAS NOTED THAT THERE WAS AN X-RAY AND INTACT PENDING FINAL RADIOLOGY REPORT. SIGNS AND SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED DECREASED COVERAGE TO LOW BACK PAIN. SURGICAL INTERVENTION HAD NOT OCCURRED BUT IT WAS COMING UP. THE COMPONENTS MARKED FOR REVISION WERE THE INS AND LEAD. THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. THE PATIENT OUTCOME WAS NON-SERIOUS ILLNESS/INJURY. THERE WERE SOME ILLEGIBLE PORTIONS ON THE FORM THE HCP RETURNED. AS A RESULT, THE HCP WAS CONTACTED AND THE HCP NOTED THAT THE RESPONSE TO PLEASE REPORT ANY ABNORMAL IMPEDANCE MEASUREMENTS WAS MARKED OUT. THERE WAS ONE OTHER ILLEGIBLE PORTION UNDER OTHER INFORMATION OF IMPORTANCE AND IT READ SCS NEEDS REVISION OF INS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS CONTACTED AND HE SAW THE PATIENT APPROXIMATELY (B)(6) 2014. THE MANUFACTURER REPRESENTATIVE STATED HE WOULD NEVER TELL THE PATIENT HE HAD WATER AROUND OR IN THE POCKET. THE MANUFACTURER REPRESENTATIVE STATED IT WAS DETERMINED THAT THERE WERE IMPEDANCE PROBLEMS. IT WAS NOTED THAT THE PATIENT HAD LEAD EXTENSION S REPLACED BUT COULD NOT REMEMBER THE EXACT DATE OR REASON. NOW, THE PATIENT NEEDED TO HAVE A REVISION. IT WAS NOTED THAT THIS WAS PLANNED FOR SOME TIME IN (B)(6). IT WAS NOTED THAT THERE WAS NOT AN EXACT DATE AS OF (B)(6) 2014. THE MANUFACTURER REPRESENTATIVE STATED HE THOUGHT HE HAD FILLED OUT AN MPXR REPORT ON THIS.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT 1 WEEK AFTER IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT THE PATIENT BEGAN TO FEEL MORE OF A SHOCKING OR JOLTING SENSATION. THE PATIENT HADN'T USED IT SINCE (B)(6) DUE BECAUSE OF THE SHOCKING OR JOLTING AND IN (B)(6) THE SHOCKING WAS TOO MUCH SO THE PATIENT'S HEALTH CARE PROVIDERS (HCPS) SCHEDULED THE PATIENT FOR A LEAD REVISION. THE LEADS WERE REPLACED ON (B)(6) 2014. THE PATIENT HAD AN AUTO ACCIDENT IN MAY WHICH DELAYED THE LEADS BEING REPLACED UNTIL (B)(6) 2014 AND THE LEADS AND EXTENSIONS WERE REPLACED AT THAT TIME. NO SHOCKING OR JOLTING WAS REPORTED AT THE TIME OF THE PATIENT'S POST-OPERATIVE VISIT. 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.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR DOCTOR OR A MANUFACTURER REPRESENTATIVE. AN APPOINTMENT DATE OF (B)(6) 2014 WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370754 | 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 | 00056 YR | Required Intervention |