RESTORE SENSOR
Report
- Report Number
- 3004209178-2017-02787
- Event Type
- Injury
- Date Received
- February 8, 2017
- Date of Event
- May 1, 2016
- Report Date
- May 25, 2017
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- UDI-DI
- 00613994610430
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
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).
(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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-39, PRODUCT TYPE: ACCESSORY. ANALYSIS OF THE INS FOUND THAT IT WAS AT END OF SERVICE (EOS) DUE TO THREE OVERDISCHARGE EVENTS WHICH LED TO REDUCED CAPACITY. ANALYSIS OF THE 3004209178-2017-02787-4 ) FOUND THAT CONDUCTOR #13 WAS BROKEN 23.5 CM FROM THE DISTAL END.
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60 , SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. IMPLANTABLE NEUROSTIMULATOR AND LEADS RETURNED, BUT ANALYSIS HAS NOT YET BEEN COMPLETED.
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.
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE AND HEALTH CARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR CHRONIC LOW BACKPAIN, RADICULOPATHY, AND SPINAL PAIN. THE PATIENT¿S MEDICAL HISTORY INCLUDED DIABETES TYPE 2, FAILED BACK SURGERY SYNDROME X4, TRANSIENT ISCHEMIC ATTACH (TIA), HYPERTENSION (HTN), CONGESTIVE HEART FAILURE (CFH), AND DEEP VEIN THROMBOSIS (DVT). INFORMATION WAS RECEIVED ON 2016-09-26 FROM THE HEALTH CARE PROFESSIONAL (HCP) WHO REPORTED THAT THE MRI WAS NOT DUE TO A DEVICE OR THERAPY ISSUE BUT FOR SYMPTOMS. THE PATIENT ALSO TOLD THE HCP THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN DEAD FOR 3-4 MONTHS. THE HCP WANTED TO KNOW HOW TO CONFIRM THAT THE INS WAS IN FACT OFF WITHOUT THE PATIENT PROGRAMMER. THE HCP CALLED BACK LATER THE SAME DAY AND STATED THAT THEY NEEDED TO PERFORM A BRAIN SCAN. THE PATIENT WAS HOSPITALIZED BUT THIS WAS NOT RELATED TO THE DEVICE. A MANUFACTURER REPRESENTATIVE WAS PAGED IN ORDER TO PERFORM THE NEEDED JUMPSTART TO THE BATTERY. ADDITIONAL INFORMATION WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE THAT THEY RECEIVED A HOSPITAL PAGE YESTERDAY THAT THE PATIENT NEEDED AN MRI. OVERDISCHARGE WAS CONFIRMED AT THE BEDSIDE IN INPATIENT ON THE DAY OF THE REPORT. THE PATIENT STATED THAT IT HAD BEEN 4 MONTHS SINCE THEY HAD RECHARGED. THE PATIENT FURTHER STATED THAT THE DEVICE HAD NOT HELPED THEM SO THEY DID NOT KEEP IT CHARGED. THE REASON FOR NOT CHARGING WAS NON-COMPLIANCE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTING THAT THE POWER ON RESET WAS SUCCESSFULLY CLEARED ON (B)(6) 2016 AFTER THE SUCCESSFUL PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED. THE MANUFACTURER REPRESENTATIVE ASKED THE PATIENT ABOUT THE LACK OF THERAPY AND WAS TOLD BY THE PATIENT THAT THEY FELT THE SCS HAD NOT HELPED SO WHY KEEP IT CHARGED AS CHARGING WAS A PAIN. THERE WAS NO FURTHER INFORMATION AVAILABLE FROM THE MANUFACTURER REPRESENTATIVE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2017 REPORTING THAT THE PATIENT GOT A PUMP IMPLANT ON (B)(6) 2017 AND WANTED THEIR SCS REMOVED. THE PATIENT HAD A HISTORY OF NON-COMPLIANCE WITH RECHARGING. THE PATIENT¿S FAMILY MEMBER ASKED FOR THE SCS TO BE EXPLANTED TODAY DURING THE PUMP IMPLANT BUT THE HEALTH CARE PROFESSIONAL (HCP) INFORMED THEM THAT IT WAS NOT APPROVED BY INSURANCE. THE PATIENT WOULD BE PRE-CERTIFIED FOR THE EXPLANT. THERE WAS NO FURTHER INFORMATION ON THE PATIENT AT THE TIME OF THE REPORT FORM THE HEALTH CARE PROFESSIONAL (HCP) OR THE MANUFACTURER REPRESENTATIVE.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE INDICATED THAT THE PATIENT UNDERWENT COMPLETE DEVICE EXPLANT ON THE DAY OF THE REPORT. THE PATIENT IS DOING WELL POST-OPERATION. THE INS IS TO BE RETURNED TO THE MANUFACTURER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95310 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 | 00613994610430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |