RESTORE ULTRA
Report
- Report Number
- 3004209178-2015-15852
- Event Type
- Injury
- Date Received
- August 12, 2015
- Date of Event
- July 17, 2015
- Report Date
- August 8, 2016
- 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
- OTHER
Narratives
(B)(4).
REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3888-33, LOT# J0454526V, IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# J0454526V, IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3888-33, LOT# J0454526V, IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# J0454526V, IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION.
CONCOMITANT: PRODUCT ID 3888-33, LOT# J0454526V, IMPLANTED: 2004-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3888-33, LOT# J0454526V, IMPLANTED: 2004-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT¿S SETTINGS HAD A GROUP B WITH TWO PROGRAMS (B1 AND B2), AND THE PATIENT WAS NOT FEELING ANY STIMULATION ON THE RIGHT LEG WITH PROGRAM B1. AMPLITUDE WAS INCREASED TO 10.5V, AND THE PATIENT DID NOT FEEL STIMULATION. THE PATIENT FELT STIMULATION IN THE LEFT LEG AND BACK ON PROGRAM B2 AT 3.6V. THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT DID NOT FEEL SHOCKING/TINGLING AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. IT WAS NOTED THAT THE PATIENT HAD FALLEN A COUPLE TIMES THIS WINTER, BUT COULD NOT CORRELATE THIS TO THE PATIENT¿S CHANGE IN THERAPY. THE MANUFACTURER REPRESENTATIVE ALSO REPORTED THAT THE STIMULATION EVENT WAS RELATED TO POSITIONAL MOVEMENT; THE PATIENT FELT STIMULATION WHILE MOVING AROUND, LAYING DOWN, OR WHEN HE PRESSED AT THE LEAD/EXTENSION CONNECTION. GROUP IMPEDANCE VALUES WERE 1782 OHMS AND 594 OHMS FOR B1 AND B2, RESPECTIVELY. THE PATIENT DID NOT FEEL ANY STIMULATION WHILE RUNNING GROUP IMPEDANCES. IMPEDANCE MEASUREMENTS WERE TAKEN AGAIN WHILE THE PATIENT WAS PRESSING HIS BACK AT THE LEAD/EXTENSION CONNECTION SITE WITH SIMILAR RESULTS; GROUP IMPEDA NCES WERE 1797 OHMS AND 585 OHMS FOR B1 AND B2, RESPECTIVELY. ELECTRODE IMPEDANCE RANGES WERE 690-1871 OHMS FOR REFERENCE ELECTRODE 0 AND 1795-4545 OHMS FOR REFERENCE ELECTRODE 1. IT WAS NOTED THAT REFERENCE ELECTRODES 2, 5, AND 6 PROVIDED SIMILAR RANGES TO THOSE PROVIDED FOR REFERENCE ELECTRODE 1. THE ELECTRODE CONFIGURATION FOR B1 WAS 1+/2- AND B2 WAS 5+/6-. DURING THE TIME OF FOLLOW UP, THE MANUFACTURER REPRESENTATIVE ATTEMPTED TO INCREASE B1 AND THE PATIENT STARTED TO FEEL IT IN HIS LEFT LEG, BUT THEN RETURNED TO NOT FEELING STIMULATION. REPORTED SYMPTOMS INCLUDED SHOCKING ON THE PATIENT¿S LEFT LEG. NO OUTCOME OR FURTHER TROUBLESHOOTING/INTERVENTIONS WERE REPORTED FOR THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT. THE PATIENT¿S INDICATIONS FOR USE ALSO INCLUDED SPINAL STENOSIS.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTING THAT THE PATIENT WAS SCHEDULED FOR AN INS REPLACEMENT FOR (B)(6) 2016. IT WAS UNKNOWN IF THE LEAD AND OR EXTENSION WOULD ALSO BE REPLACED. ACCORDING TO THE MANUFACTURER REPRESENTATIVE'S NOTES FROM (B)(6) THE PATIENT WAS NOT GETTING GOOD STIMULATION, HAD A FEW FALLS BUT COULD NOT CORRELATE THE FALLS TO THE STIMULATION ISSUES, AND THAT THE PATIENT HAD BEEN GETTING JOLTING NEAR THE LEAD/EXTENSION CONNECTION SITE.
ADDITIONAL INFORMATION NOTED THAT THEY TRIED TO REPROGRAM THE DEVICE ON (B)(6) 2016 BUT THEY WERE UNSUCCESSFUL AND THAT THE CAUSE OF THE EVENT WAS UNKNOWN.
THE PATIENT REPORTED SHOCKING ONCE BEFORE STARTING A CHARGE SESSION. THE STIMULATION CHANGE WAS REPORTED TO HAVE BEEN RELATED TO POSITIONAL MOVEMENT; THE PATIENT THOUGHT IT MAY HAVE BEEN WHILE GETTING READY TO SIT TO RECHARGE. HE FELT THE JOLT ONCE AND HAD NOT FELT IT SINCE. NO FALLS/TRAUMA OR MEDICAL TEST/ELECTROMAGNETIC INTERFERENCE (EMI) WERE INVOLVED. THE JOLT WAS NOTED TO BE SUDDEN BUT THE PATIENT HAD NOT CHECKED THE DEVICE WITH THEIR PATIENT PROGRAMMER (PP). RELEVANT MEDICAL HISTORY INCLUDED NON-MALIGNANT PAIN. FOLLOW-UP WAS PERFORMED TO DETERMINE WHAT STEPS WERE TAKEN TO TROUBLESHOOT/RESOLVE THE SHOCKING/JOLTING ISSUE. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 530150 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Required Intervention |