PRIMEADVANCED
Report
- Report Number
- 3004209178-2013-03002
- Event Type
- Injury
- Date Received
- February 25, 2013
- Report Date
- February 5, 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
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL REVIEW INDICATED THAT THE INCORRECT DATE WAS ENTERED INTO THE RECEIVED ON DATE IN THE PREVIOUSLY SUBMITTED REPORT. THE DATE HAS BEEN CORRECTED TO (B)(4) 2013.
(B)(4).
(B)(4).
PRODUCT ID 749851, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: EXTENSION. PRODUCT ID 74001, LOT# N283728, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID 3998, LOT# L59478, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: LEAD. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3550-09, LOT# LA7205, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: ACCESSORY. (B)(4).
IT WAS INITIALLY REPORTED THAT THE PATIENT HAD "PERSISTENT AND INCREASED PROBLEMS" SINCE BATTERY REPLACEMENT (SEE MFR. REP #6000032-2012-00161). IT WAS STATED THAT THE PATIENT COULD NOT "USE IT AT ALL". THE FOLLOWING DAY, IT WAS NOTED THAT THE PATIENT "WASN'T GETTING THE COVERAGE THE SAME". IT WAS STATED THAT ELECTRODES 4, 5, 6, AND 7 HAD IMPEDANCE READINGS OF GREATER THAN 10,000 OHMS, BUT LATER STATED IMPEDANCE READINGS WERE GREATER THAN 4,000 OHMS. IT WAS NOTED THAT THE PATIENT HAD HIGH IMPEDANCE PREVIOUSLY (SEE MFR. REP # 6000032-2012-00193). IT WAS INDICATED THAT THE PATIENT WAS SCHEDULED FOR A REVISION. THE PATIENT REPORTEDLY STILL FELT SPASMS IN HER LEG WHEN THE DEVICE WAS ON, WHICH WENT AWAY WHEN THE DEVICE WAS TURNED OFF (SEE MFR. REP. # 6000032-2012-00193). THREE WEEKS LATER, IT WAS REPORTED THAT THE PATIENT HAD "SPASMS PERIODICALLY" AND "UNEXPECTEDLY'. IT WAS NOTED THAT THEY WERE "PAINFUL AND UNCONTROLLABLE". IT WAS STATED THAT THE PATIENT HAD THE SPASMS WHETHER OR NOT THE STIMULATION WAS ON OR OFF. IN (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT WAS HAVING "SEVERE" SPASMS THAT COVERED THE ENTIRE AREA THAT THE DEVICE WAS SUPPOSED TO COVER FOR PAIN. IT WAS STATED THAT A TEST OF THE SYSTEM AFTER THE IMPLANT IN (B)(6) 2012 SHOWED A "PROBLEM WITH LEADS". IT WAS NOTED THAT SURGERY WAS SCHEDULED AND LATER CANCELLED DUE TO "SEVERAL RANDOM REPEAT OF SPASM WHILE THE SYSTEM WAS OFF FOR 6 DAYS". IT WAS FURTHER NOTED THAT A SECOND MANUFACTURER REPRESENTATIVE DENIED ANY ISSUES WITH THE SYSTEM. THE PATIENT REPORTEDLY HAD NOT EXPERIENCED A SPASM SINCE TURNING THE DEVICE OFF. IT WAS FURTHER STATED THAT "OTHER SYMPTOMS" ALSO RESOLVED AT THE SAME TIME AND WERE CONNECTED TO THE CONSTANT "OVERSTIMULATION". IT WAS STATED THAT THE PATIENT'S DEVICE HAD BEEN OFF SINCE (B)(6) 2012 AND NERVES HAD BEEN "OK". THE PATIENT REPORTEDLY HAD NOT HAD SPASMS SINCE THE DEVICE WAS TURNED OFF, BUT EXPERIENCED AN INCREASE IN MYOCLONIC JERKS WHICH HAD BEEN "QUIET FOR A LONG TIME". IT WAS NOTED THAT THE PATIENT COULD NOT CONTINUE TO TAKE MEDICATIONS DUE TO THE RESPONSES SHE HAD TO THEM. IT WAS STATED THAT THERE WAS A "TELEMETRY READOUT PROBLEM" ON (B)(6) 2012. THREE MONTHS FROM THE INITIAL REPORT, IT WAS REPORTED THAT THE PATIENT WAS HAVING "SIGNIFICANT MYOCLONIC JERKS BUT NOT SPASMS" WHILE THE DEVICE WAS OFF. IT WAS STATED THAT THE MANUFACTURER REPRESENTATIVE DENIED ANY ISSUE WITH THE LEADS OR IMPLANT, BUT INDICATED THAT THE ISSUE WAS THE PATIENT'S NERVES. A MONTH LATER, IT WAS REPORTED THAT THE PATIENT EXPERIENCED "OVERSTIMULATION" AND A "SHOCKING OR JOLTING SENSATION." IT WAS STATED T HAT WITH STIMULATION ON, SHE HAD PAIN FROM OVERSTIMULATION RATHER THAN PAIN RELIEF. IT WAS NOTED THAT THE PATIENT HAD TO "PERMANENTLY" TURN OFF THE DEVICE AS SHE WAS HAVING "MASSIVE SEIZURE-LIKE SPASMS" BECAUSE THE SPASMS COULD NOT BE CONTROLLED. IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE "CONVULSING PAIN" WHEN THE DEVICE WAS TURNED OFF. FLUOROSCOPY WAS PERFORMED "A COUPLE OF WEEKS" PRIOR TO THE REPORT AND IT WAS STATED THAT "THE LEADS ON ONE OF THE STRIPS WAS NOT ATTACHED - THE FIRST COUPLE TWO OR THREE LEADS HAD PULLED AWAY FROM ATTACHMENT - THEY SAID THEY SOMETIMES SAW THAT IN OLD SYSTEMS". IT WAS NOTED THAT THE PATIENT'S PAIN HAD BEEN UNCONTROLLABLE THE WEEKEND PRIOR TO THE REPORT SO THE PATIENT HAD TURNED THE DEVICE ON. IT WAS FURTHER NOTED THAT THE SPASMS RETURNED AFTER "A FEW DAYS" SO SHE TURNED THE DEVICE OFF AGAIN. SEE MFR. REP # 6000032-2012-00161. THE PATIENT HAS BEEN REDIRECTED TO THEIR HCP. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEADS AND ELECTRODES WERE REPLACED ON (B)(6) 2013 BECAUSE ¿THERE WAS A PROBLEM¿ AND THE PATIENT¿S HEALTHCARE PROVIDER COULDN¿T IDENTIFY THE PROBLEM. IT WAS NOTED THAT THE PATIENT THOUGHT THAT THE HEALTHCARE PROVIDER ¿REALLY WOULDN¿T ADMIT TO THE PROBLEM. THE REPORTER STATED THAT THE HEALTHCARE PROVIDER TOLD THE PATIENT FAMILY THAT THERE WAS A BREAK IN THE LEAD AND THE COVERING HAD WORN, AND WHEN THE PATIENT MET WITH THE FOLLOW-UP UP HEALTHCARE PROVIDER IT WAS NOT ACKNOWLEDGED. IT WAS REPORTED THAT THE PATIENT STILL HAD SYMPTOMS BUT THEY WEREN¿T ¿NEARLY AS BAD¿ AS BEFORE HAVING THE LEAD REPLACED.
IT WAS REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. REPROGRAMMING WAS PERFORMED ON AN UNKNOWN DATE. THE PATIENT EXPERIENCED BILATERAL LOWER EXTREMITY FLEXION SPASMS. IT WAS NOTED THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. IT WAS ALSO REPORTED THERE WAS NO EVIDENCE OF SOMATIC PHYSIOLOGIC DYSFUNCTION.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD TO TURN STIMULATION OFF BECAUSE IT WAS CAUSING SPASMS, AND THE SPASMS DECREASED SIGNIFICANTLY AFTER TURNING STIMULATION OFF. IT WAS NOTED THAT ONCE IT HAD BEEN ¿OVERSTIMULATED¿ IT COULD TAKE SEVERAL WEEKS FOR THE SPASMS TO STOP.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DOCTOR HAD BEEN UNABLE TO FIND "ANY CORRELATION WHATSOEVER" BETWEEN THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE ISSUES THE PATIENT HAD BEEN EXPERIENCING. IT WAS NOTED THAT THE DOCTOR HAD TURNED THE INS OFF AND THE PATIENT WOULD STILL SAY SHE WAS HAVING ISSUES. THE REPORTER STATED THAT THE DOCTOR DID THE LEAD REVISION IN (B)(6) "JUST TO APPEASE THE PATIENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80493 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Required Intervention |