RESTORE ADVANCED
Report
- Report Number
- 3004209178-2013-10376
- Event Type
- Injury
- Date Received
- June 14, 2013
- Date of Event
- May 23, 2013
- Report Date
- June 18, 2018
- 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
(B)(4).
ANALYSIS OF THE LEAD, SERIAL #(B)(4) FOUND NO ANOMALY UPON ANALYSIS.
PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).
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).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS NOTED THAT THERE WERE HIGH IMPEDANCES ON 10 AND 12. THE DAY OF THE REPORT THE PATIENT WENT ¿BACK IN¿ AND THE LEAD WAS REPLACED AND HAD HIGH IMPEDANCES ON 6, 7, AND 8 WHICH WERE NOT RESOLVED. IT WAS NOTED THAT THE PATIENT NEEDED THOSE CONTACTS FOR THERAPY AND THERE WAS CONCERN REGARDING CLOSING WITH THAT STATUS. THE LEAD WAS REPLACED AGAIN DURING THE SAME SURGERY.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING/JOLTING ISSUE THAT STARTED 1 YEAR AGO. IT WAS STATED THAT THE SYMPTOMS WERE LOCATED IN THE SAME AREA AS NORMAL STIMULATION COVERAGE. IT WAS ALSO STATED THAT THE POCKET SITE HURT WHEN TOUCHED. IT WAS FURTHER STATED THAT X-RAYS CONFIRMED THAT THE EXTENSIONS WERE CROSSING. REPROGRAMMING WAS REPORTEDLY DONE AND A SURGICAL PROCEDURE WAS DONE A FEW MONTHS AGO TO TRY TO RESOLVE THE ISSUE. THE EXTENSIONS WERE REPLACED; THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) REMAINED. IT WAS ADDED THAT THE EXTENSION/LEAD CONNECTION WAS MOVED TO THE SPINE AREA TO AVOID THE DISCOMFORT THE PATIENT WAS EXPERIENCING. IT WAS STATED THAT THE PATIENT WAS GOOD FOR TWO WEEKS, BUT NOW REPORTS THE SAME SHOCKING/JOLTING AND OVERSTIMULATION SENSATION THAT OCCURRED RANDOMLY. IMPEDANCE MEASUREMENTS WERE TAKEN AND WERE WITHIN NORMAL RANGE (RANGED FROM 600 TO 1500 OHMS), EXCEPT CONTACTS 10 AND 12, WHICH INTERMITTENTLY READ LESS THAN 150 OHMS OR NORMAL RANGE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE TRIED TO PROGRAM ONLY ON ELECTRODES 0 THRU 7, BUT IT DID NOT HELP THE PATIENT¿S PAIN. IT WAS STATED THAT THE SHORT WAS WITH THE SURGICAL LEAD AND THE PATIENT DID NOT WANT IT REPLACED AT THIS TIME. THE MANUFACTURER REPRESENTATIVE WAS TO MEET WITH THE PATIENT ON FRIDAY TO SEE IF THEY COULD USE ALTERNATE PROGRAMS. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. PLEASE REFER TO MFG. REPORT # 3004209178-2012-06848, AS THIS REPORT PERTAINS TO THE START TO THE ONGOING ISSUE OF SHOCKING/JOLTING THAT BEGAN A YEAR AGO.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BEING BOOKED FOR A SURGICAL PADDLE REVISION.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING WELL AND IMPEDANCES WERE ALL NORMAL.
ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT REPORTING THAT THEY HAD SOME BROKEN CONTACTS ON THE BOTTOM OF THE LEAD PADDLE AND THAT IMPENDANCES WERE RUN AT 3V AND NOTHING WAS OUT OF RANGE. THIS INFORMATION WAS CONTRADICTORY TO PREVIOUS REPORTS. IT WAS ALSO REPORTED THAT THEY DID NOT CHANGE THE REFERENCE ELECTRODE ON THE DROP DOWN. IT WAS REPORTED THAT THE PATIENT WAS GETTING THERAPY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ISSUE RESOLVED AFTER EXTENSION REPLACEMENT FOR TWO MONTHS. THE SHOCKING CAME BACK AT FIRST PERIODICALLY AND THEN BECAME MORE FREQUENT AND MORE SEVERE. THE DAY OF THE REPORT THE PATIENT WENT "BACK IN" AND THE LEAD WAS REPLACED. THE LEAD WAS REPLACED AGAIN DURING THE SAME SURGERY AFTER A DIFFERENT ISSUE AND IT WAS MOVED OFF MIDLINE WHICH RESOLVED THE ISSUE. THE PATIENT HAD GOOD COVERAGE AT THE TIME. PRIOR TO THE SECOND NEW LEAD, ALL TROUBLESHOOTING HAD BEEN EXHAUSTED. IT WAS NOTED AT THE END OF THE REPORT THAT ALL SHOCKING ISSUES STARTED AFTER AN AUTO ACCIDENT IN WHICH THE PATIENT WAS REAR ENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271935 | 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 | 00052 YR | Required Intervention |