SURESCAN
Report
- Report Number
- 3004209178-2015-00210
- Event Type
- Injury
- Date Received
- January 6, 2015
- Report Date
- December 8, 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
- NV, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3986A, LOT# N072015N01, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3986A, LOT# N062693, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3986A, LOT# N072015N01, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3986A, LOT# N062693, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
ANALYSIS OF THE EXTENSION, SERIAL # (B)(4), DETERMINED THAT THE #0 CONDUCTOR WAS BROKEN 1.7 CM FROM THE PROXIMAL END. ANALYSIS OF THE LEAD, LOT # N072015N01, DETERMINED THAT THERE WAS METAL ION OXIDATION ON THE OUTER INSULATION OF THE PROXIMAL END. ANALYSIS OF THE LEAD, LOT # N062693, DETERMINED THAT THERE WAS METAL ION OXIDATION ON THE OUTER INSULATION OF THE PROXIMAL END.
CORRECTED INFORMATION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ID 3986A LOT# N072015N01, IMPLANTED: 2009 (B)(6) PRODUCT TYPE LEAD PRODUCT ID 3986A LOT# N062693, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3986A, LOT# N072015N01, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3986A, LOT# N062693, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING PROBLEMS WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) SINCE REPLACEMENT. IT WAS TO THE POINT THAT THE ENTIRE LEFT SIDE WAS NOT WORKING PROPERLY AND THE PATIENT NEEDED TO HAVE A MANUFACTURING REPRESENTATIVE LOOK AT IT TO SEE IF IT WAS SOMETHING AS SIMPLE AS RESETTING IT OR IF SHE NEEDED ANOTHER SURGERY. THE PATIENT WAS IN A LOT OF PAIN. IT WAS NOTED THAT THE PATIENT¿S STIMULATION WAS INTERMITTENT. THE PATIENT HAD OCCIPITAL OR PERIPHERAL SYSTEM FOR MIGRAINES. THE PATIENT HAD LEFT AND RIGHT SIDED COVERAGE. THE PATIENT WAS HAVING PROBLEMS WITH THE STIMULATION TURNING ON AND OFF ON THE LEFT SIDE. THE RIGHT SIDE ALWAYS REMAINED ON. AT THE BEGINNING OF THE APPOINTMENT, THE PATIENT WAS FEELING STIMULATION ON THE LEFT AND RIGHT SIDE. THE MANUFACTURING REPRESENTATIVE PERFORMED 3 ELECTRODE IMPEDANCE TESTS. WITH THE FIRST TEST AND A REFERENCE AS 0, THE #8 ELECTRODE WAS GREATER THAN 10,000 OHMS. WHEN THE PATIENT MOVED THEIR HEAD, THE LEFT SIDE STIMULATION SENSATION WENT AWAY. THE MANUFACTURING REPRESENTATIVE RECHECKED THE IMPEDANCES AND WITH REFERENCE AS THE 0 ELECTRODE THE #1 CONTACT WAS GREATER THAN 10,000 OHMS. THE THIRD CHECK WAS AT 1.5V AND HIGH IMPEDANCES WERE FOUND. SINCE THE PATIENT¿S REVISION IN AUG (B)(6), THEY HAD THIS ON AND OFF ACTIVITY ON THE LEFT SIDE. ALL IMPEDANCES WERE FINE AT THE END OF THIS PROCEDURE. THE 0-3 LEAD WAS FOR THE LEFT SIDE AND THE 8-11 LEAD WAS FOR THE RIGHT SIDE. IT WAS NOTED THAT THE OPEN CIRCUIT WAS ON CONTACT 0. THE PATIENT FELT STIMULATION WHEN THE CONFIGURATION WAS CHANGED. THE PATIENT COULD MOVE THEIR HEAD WITH THE LEFT SIDE NOT CUTTING IN OR OUT. IT WAS FURTHER NOTED THAT ¿SOMETIMES THE 8 ELECTRODE WAS OUT OF RANGE AND SOMETIMES THE 1 ELECTRODE. IT WAS NOTED THAT THE 0 ELECTRODE COULD BE THE ISSUE AND IT WAS TAKEN OUT OF THE PROGRAMMING. REPROGRAMMING TO AVOID CONTACT 0 RESOLVED THE SITUATION. AFTER TROUBLESHOOTING, IT WAS DETERMINED THAT THE 0 ELECTRODE WAS THE PROBLEM, EVEN THOUGH DIFFERENT ELECTRODES WOULD HAVE ABNORMAL IMPEDANCES AT DIFFERENT TIMES. THE MANUFACTURING REPRESENTATIVE WAS ADVISED NOT TO HAVE THAT 0 ELECTRODE PROGRAMED OR IT MAY SHORT IN AND OUT. ONCE THAT ELECTRODE WAS REPROGRAMMED STIMULATION CAME BACK ON. THE PATIENT CALLED IN LATER IN THE DAY AND SAID THAT HER COVERAGE WAS NOT AS HIGH UP ON HER HEAD AS IT WAS. THE LEFT SIDE COVERAGE WAS NOT GOING UP THE BACK OF THE PATIENT¿S HEAD AS SHE NEEDED IT AND IT DIDN¿T RELIEVE THE SYMPTOMS. THIS WAS BECAUSE THE 0 ELECTRODE COULD NOT BE PROGRAMMED. A DIFFERENT MANUFACTURING REPRESENTATIVE SAW THE PATIENT ON (B)(6) 2014 AND REPROGRAMMED TO INCLUDE THE 0 CONTACT. THE PATIENT¿S STIMULATION WENT BACK TO ¿CUTTING IN AND OUT.¿ THEY WERE CONSIDERING HAVING A REVISION AS THE DEVICE CUT OUT AND IN WHEN THE PATIENT FLEXED HER HEAD FORWARD AND WHEN SHE EXTENDED HER HEAD BACK, THE COVERAGE GOT BETTER. THERE WAS NOT MUCH SLACK BETWEEN THE LEADS AND EXTENSIONS. THE PATIENT¿S IMPEDANCES DIFFERED WITH POSITION. WITH THE HEAD FORWARD, THE PATIENT FELT PINS AND NEEDLES AND HIGH IMPEDANCES WERE FOUND ON ALL OF THE CONTACTS WITH 0 AS A REFERENCE ELECTRODE. THESE IMPEDANCES RANGED FROM GREATER THAN 4,000 OHMS TO GREATER THAN 15,000 OHMS. WHEN USING 2 AS A REFERENCE, HIGH IMPEDANCES WERE FOUND ON SOME OF THE CONTACTS. WITH THE HEAD BACK, AND USING 0 AS A REFERENCE, ALL OF THE IMPEDANCES WERE HIGH, RANGING FROM GREATER THAN 4,000 OHMS TO GREATER THAN 15,000 OHMS. WITH 1 AS A REFERENCE, ALL IMPEDANCES WERE HIGH, RANGING FROM GREATER THAN 11,000 OHMS TO GREATER THAN 15,000 OHMS. THE MANUFACTURING REPRESENTATIVE DISCUSSED REPLACING THE EXTENSIONS FIRST AND CHECKING THE IMPEDANCES AND IF THAT DID NOT WORK, TESTING THE LEADS A POSSIBLY REPLACING THEM. THE PATIENT HAD NOT HAD AN X-RAY SINCE (B)(6) 2014. THE DEVICE WAS GETTING WORSE AND WAS NOT HELPING THE PATIENT. THE PATIENT NOTED THAT ¿IT DID FEEL LIKE THERE WAS A PROBLEM AT THE LEAD AND EXTENSION CONNECTION.¿ THE PROBLEMS STARTED WHEN THE PATIENT WAS ABLE TO MOVE HER HEAD AFTER SURGERY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEADS AND EXTENSIONS WERE REPLACED ON (B)(6) 2015. THE PATIENT HAD NOT BEEN SEEN FOR THE FOLLOW UP APPOINTMENT SINCE SURGERY, HOWEVER ALL IMPEDANCES WERE GOOD POST-OP AND THE PATIENT WAS GETTING STIMULATION APPROPRIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7798 | SURESCAN | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 97712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |