RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-10650
- Event Type
- Injury
- Date Received
- June 20, 2013
- Report Date
- May 31, 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
- NC, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 39565-30 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708120 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708120 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).
(B)(4).
(B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (S/N (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE LEAD (S/N (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE FIRST EXTENSION (S/N (B)(4)) FOUND NO ANOMALY. ANALYSIS OF THE SECOND EXTENSION (S/N (B)(4)) FOUND THE STIM EXTENSION BODY CONDUCTOR WAS BROKEN WITHIN 10 CM OF THE CONNECTOR AREA. ANALYSIS OF THE FIRST ANCHOR FOUND NO SIGNIFICANT ANOMALY, THE STIM ANCHOR WAS SEPARATED. ANALYSIS OF THE SECOND ANCHOR FOUND NO SIGNIFICANT ANOMALY, THE STIM ANCHOR WAS SEPARATED.
IT WAS REPORTED, THE PATIENT EXPERIENCED INTERMITTENT STIMULATION FOLLOWING A FALL. IT WAS STATED, THE PATIENT ¿FELL A LOT¿ AND WAS NOTED TO HAVE FALLEN ¿JUST A FEW DAYS¿ PRIOR TO REPORT. IT WAS REPORTED, THE STIMULATION ISSUE ¿STARTED IN THE LAST DAY OR TWO¿ PRIOR TO REPORT AND THE PATIENT ¿SUSPECTED THE FALL MAY HAVE CAUSED A SHORT.¿ IT WAS STATED, THE PATIENT¿S STIMULATION ¿CUTS IN AND OUT¿ AND THAT SHE ¿MOSTLY DIDN¿T FEEL STIMULATION.¿ IT WAS NOTED THAT ¿SOMETIMES WITH CERTAIN MOVEMENTS OR POSITIONS SHE COULD GET IT BACK.¿ THE PATIENT WAS REDIRECTED TO HER HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT ELECTRODES 8 THROUGH 15 WERE HIGH IMPEDANCES, GREATER THAN 10,000 OHMS, AND SOME ELECTRODES ON 0 THROUGH 8 WERE LESS THAN 50 OHMS WHEN USING CERTAIN COMBINATIONS. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF AND INCREASED STIMULATION AT THE DEVICE POCKET, LEAD AND EXTENSION CONNECTION, AND LEAD LOCATION. REPROGRAMMING WAS ALSO PERFORMED, HOWEVER, NO DETAILS WERE PROVIDED. THE PATIENT WAS SCHEDULED TO SEE HER PAIN DOCTOR ON (B)(6) 2013.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN BY THE HEALTHCARE PROFESSIONAL (HCP) ON 2013 (B)(6) AND IT WAS DETERMINED THAT THEY BE REFERRED TO ANOTHER HCP FOR REPLACEMENT OF THE LEAD AND GENERATOR. THERE WAS NO DATE FOR THE INTERVENTION AT THIS TIME. IT WAS NOTED THAT IMPEDANCE CHECKS WERE DONE. THE CAUSE OF ISSUE WAS NOT DETERMINED. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY.
ADDITIONAL INFORMATION REPORTED THE PATIENT THOUGHT THEY HAD A SHORT IN THEIR "WIRES." IT WAS STATED THE PATIENT FELL ONE WEEK PRIOR TO REPORT AND THEY THOUGHT THEY GOT THE "WIRES KINKED." ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD AN APPOINTMENT WITH A NEUROSURGEON APPROXIMATELY ONE MONTH FOLLOWING THE DAY OF REPORT. IT WAS FURTHER REPORTED THE PATIENT'S SYSTEM WAS REPLACED WITH A NEW LEAD AND INS. IT WAS STATED ON (B)(6)2013 THE MANUFACTURER REPRESENTATIVE TURNED THE PATIENT'S SYSTEM ON AND SHOWED THE PATIENT HOW TO CHARGE. IT WAS STATED THE LEAD, EXTENSIONS, AND THE INS WERE REMOVED AND SENT BACK TO THE MANUFACTURER. IT WAS NOTED THE CAUSE OF THE ISSUE WAS NOT KNOWN. IT WAS STATED THE PATIENT WAS DOING WELL WITH THE NEW SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281103 | 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 | Required Intervention |