RESTORE SENSOR
Report
- Report Number
- 3004209178-2018-24724
- Event Type
- Malfunction
- Date Received
- November 5, 2018
- Date of Event
- October 14, 2018
- Report Date
- December 14, 2018
- 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
- IL, US
- Reporter Occupation
- 003
Narratives
MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37761 LOT# SERIAL# UNKNOWN PRODUCT TYPE RECHARGER ANALYSIS OF THE DESKTOP CHARGER (SERIAL #UNKNOWN) FOUND THAT CONNECTOR PIN BENT FDM AND FDC APPLIED TO DESKTOP CHARGER MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37761 LOT# SERIAL# (B)(4) PRODUCT TYPE RECHARGER CORRECTION, REVIEW DETERMINED CERTAIN FDR, FDM, AND FDC CODES SHOULD BE UPDATED. THE UPDATED AND CURRENT CODES ARE: FDC CODE 4315 APPLIES TO THE RECHARGER C0521733. FDC CODE 67 APPLIES TO THE IMPLANTABLE NEUROSTIMULATOR. FDM 10 AND FDR 3251 APPLY TO THE RECHARGER. FDM 4114 AND FDR 3221 APPLY TO THE IMPLANTABLE NEUROSTIMULATOR. CORRECTION, THE DATE MFR RECEIVED FOR REPORT 3004209178-2018-24724 WAS INITIALLY GIVEN AS 2018-10-15, IT SHOULD BE 2018-10-14 H3: ANALYSIS OF THE DESKTOP CHARGER C0521733 FOUND IT HAD A BROKEN, BENT CONNECTOR, AND THE PINS WERE DAMAGED MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.
ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT. PATIENT STATED THE REPLACEMENT OF DESKTOP CHARGER RESOLVED THE INS NOT WORKING AND GETTING NO BOXES. NO FURTHER COMPLICATION AND NO SYMPTOMS WERE REPORTED.
OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37761. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ID 37761 LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER DEVICE WAS RETURNED AND NO ANALYSIS RESULT YET . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR COMPLEX REG PAIN SYNDROME TYPE I AND SPINAL PAIN. IT WAS REPORTED THE PATIENT COULD NOT GET HER IMPLANT BATTERY RECHARGED. PATIENT STATED THE INS WAS WORKING FOR A COUPLE OF DAYS. PATIENT STATED SHE WAS IN A HOSPITAL JUST ABOUT A YEAR AGO FOR A BROKEN LEG WHICH WAS UNRELATED TO THE INS. PATIENT STATED DURING THAT TIME, SHE CHARGED HER INS ONCE BECAUSE IT WAS SUCH A HASSLE WITH EVERYONE THERE NOT UNDERSTANDING, SO THEY JUST NEGATED THE INS. PATIENT NOTED SHE HAD NOT NEEDED THE INS AFTERWARD BECAUSE IT WAS THE OTHER LEG, NOT THE LEG WITH THE PAIN. PATIENT STATED SO, SHE JUST CONTINUED NOT TO USE THE INS. IT WAS NOTED WHEN PATIENT STARTED TO NEED THE INS GAIN, SHE WENT TO USE IT AND IT DID NOT WORK. PATIENT SERVICES ASKED WHEN THE LAST TIME WAS SHE CHARGED THE INS, PATIENT STATED SHE CHARGED ON FRIDAY AND IT WORKED. IT WAS MENTIONED THE INS RECHARGER¿S SCREEN WAS BLANK AND SHE COULD NOT GET ANYTHING, NO BOXES. PATIENT STATED THE GREEN LIGHT WAS ON AND DESKTOP CHARGER WAS GOOD. A REPLACEMENT DESKTOP CHARGER WOULD BE SENT TO PATIENT, CONNECTOR PIN WAS BENT. IT WAS NOTED INS RECHARGER WAS NOT CHARGING, PATIENT HAD PAIN IN LEG, AND INS DIDN'T WORK WHEN NEED TO USE IT AGAIN. IT WAS MENTIONED PATIENT COULDN'T CHARGE HER NEURO STIM AND PATIENT HAD A PROBLEM WITH HER PROGRAM FOR HER PAIN STIM. NO FURTHER COMPLICATION AND NO SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 880324 | 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 | 69 YR |