RESTORE
Report
- Report Number
- 3004209178-2014-07347
- Event Type
- Injury
- Date Received
- April 16, 2014
- Date of Event
- March 23, 2014
- Report Date
- April 15, 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
- AZ, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 37714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37743, SERIAL#(B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 74002, LOT# N346974, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION PRODUCT ID 74002 LOT# N202767 SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ADAPTER. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3986A, LOT# LB9304, IMPLANTED: (B)(6) 2004 PRODUCT TYPE: LEAD. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# LA1828, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 3998, LOT# L92553, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. (B)(4).
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37714, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 74002, LOT# N346974, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 74002, LOT# N202767, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ADAPTER. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3986A, LOT# LB9304, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_INS_STIMULATOR, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3986A, LOT# LB9304, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 3998, LOT# LA1828, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 3998, LOT# L92553, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S REVISION WAS DONE ON THE WEEK PRIOR TO THIS REPORT. IT WAS NOTED THAT AN EXTENSION WAS REMOVED. IT WAS STATED THAT THE PATIENT WAS RECEIVING EFFECTIVE STIMULATION.
IT WAS REPORTED THAT THE PATIENT WAS IN AN ACCIDENT RECENTLY AND STIMULATION CHANGED FOLLOWING THE ACCIDENT. IT WAS NOTED THAT THE STIMULATION WAS NOT REACHING WHERE IT WAS PRIOR TO THE ACCIDENT. IT WAS NOTED THAT THE ACCIDENT WAS ON SUNDAY. IT WAS NOTED THAT THE PATIENT WAS PROGRAMMED, IT WAS THE LEFT SIDE LEADS THAT WERE THE PROBLEM AND ONLY 2 POINTS OF CONTACTS, ELECTRODES 4 AND 5 ARE ABLE TO GET STIMULATION. IT WAS NOTED THAT THE STIMULATION WAS NOT IN THE CORRECT LOCATION. IT WAS NOTED THAT IMPEDANCE MEASUREMENTS SHOWED: 0: ALL GREATER THAN 3600, 2: 0, 1, 6 WERE GREATER THAN 3600 AND OTHERS AROUND 1200 OHMS, 3: 0, 1, 6 WERE GREATER THAN 3600 AND OTHERS AROUND 1200 OHMS, 3: 0, 1, 6 WERE GREATER THAN 3600 AND OTHERS AROUND 1200 OHMS, 4: 0, 1, 6 WERE GREATER THAN 3600 AND OTHERS AROUND 1200 OHMS, 5: 0, 1, 6 WERE GREATER THAN 3600 AND OTHERS AROUND 1200 OHMS, 6: ALL GREATER THAN 3600, 7: 0, 1, 6 WERE GREATER THAN 3600 AND OTHERS AROUND 1200 OHMS, AND ELECTRODES 8-15 WERE ALL NORMAL IN REFERENCE WITH CONTACTS8-15. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO FURTHER INFORMATION AT THIS TIME. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL ELECTRODES WERE HIGH. IT WAS NOTED THAT THEY WERE 10,000. IT WAS NOTED THAT NO ACTION WAS REQUIRED. IT WAS NOTED THAT IMPEDANCE TESTING AND X-RAYS WERE PERFORMED. IT WAS NOTED THAT THE PATIENT HAD AN ACCIDENT AND WAS HOSPITALIZED A FEW WEEKS PRIOR TO REPORT. IT WAS NOTED THAT ALL IMPEDANCES WERE HIGH AND THE PATIENT STILL RECEIVED STIMULATION. IT WAS NOTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS NOTED THAT THE PATIENT WAS DOING FINE AND HAD BEEN DISCHARGED FROM THE HOSPITAL FOR A FEW WEEKS BY THE TIME OF REPORT. IT WAS NOTED THAT THE PATIENT RECEIVED STIMULATION WHERE NEEDED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S HCP HAD SCHEDULED A REVISION FOR (B)(6) 2014.
ACCORDING TO THE PATIENT, ONE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED (B)(6) 2014 DUE TO THE INS "NOT WORKING." THE UNIT WOULD "SHORT OUT" AND "SPIKE" THE PATIENT. THE EVENT DATE FOR THE INS "NOT WORKING" WAS AROUND (B)(6) 2014. REFER TO REPORT # 3004209178-2014-07349 FOR A SECOND INS THAT THE PATIENT HAD IMPLANTED AT THE SAME TIME AS THIS ONE. ALSO, REFER TO MANUFACTURER REPORT # 3004209178-2014-12446 FOR CONTINUED ISSUES AFTER THE INS REPLACEMENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE X-RAYS SHOWED THE PATIENT铠LEADS HAD NOT MOVED. IT WAS REPORTED REPROGRAMMING WAS SUCCESSFUL AND THE STIMULATION WAS LIMITED TO THEIR LEFT TEMPLE. IT WAS NOTED NO MALFUNCTIONS WERE SEEN AS THE CAUSE OF THE EVENT AND NO FURTHER INTERVENTIONS WERE PLANNED OR TAKEN.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS PREPARING FOR A REVISION ON FRIDAY. IT WAS NOTED THAT THE PATIENT HAD AN ACCIDENT AND WAS HOSPITALIZED. IT WAS NOTED THAT THE PATIENT WAS VERY ACCIDENT PRONE AND HAD OCCIPITAL LEADS. IT WAS NOTED THAT THE PATIENT WAS NOT GETTING PARESETHIA TO ALLEVIATE MIGRAINES AND THE HEALTHCARE PROFESSIONAL (HCP) WAS NOT SURE WHAT THEY WOULD NEED TO REPLACE. IT WAS NOTED THAT IMPEDANCES WERE CHECKED AND THEY WERE OFF BUT THE PATIENT WAS STILL GETTING PARESETHIA. IT WAS NOTED THAT THE PATIENT LANDED ON HIS HEAD AND THE PHYSICIAN SUSPECTED THAT THE LEADS MOVED OR GOT DAMAGED. IT WAS NOTED THAT X-RAYS HAD BEEN DONE AND THE HEALTHCARE PROFESSIONAL (HCP) HAD THOSE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A BATTERY REPLACEMENT ON (B)(6) 2014 THAT IS CONNECTED TO THE OCCIPITAL LEADS. IT WAS NOTED THAT THE REPLACEMENT BATTERY DID NOT RESOLVE THE ISSUE. IT WAS NOTED THAT THE LEADS HAD HIGH IMPEDANCES AS THEY DID BEFORE. IT WAS NOTED THAT THE DOCTOR WAS PLANNING TO REVISE THE LEADS. IT WAS NOTED THAT THE DATE AND COMMITMENT TO REVISE THE LEADS WAS TO BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232799 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | Required Intervention |