SURESCAN
Report
- Report Number
- 3004209178-2019-11794
- Event Type
- Malfunction
- Date Received
- June 18, 2019
- Report Date
- July 25, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169109506
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-45, LOT# V974727, IMPLANTED: (B)(6) 2012 AND PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# V542025, IMPLANTED: (B)(6) 2010 AND PRODUCT TYPE: LEAD. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.
CONTINUATION OF D11: PRODUCT ID 3888-45 LOT# V974727, IMPLANTED: (B)(6) 2012, EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3888-33 LOT# V542025, IMPLANTED: (B)(6) 2010, EXPLANTED: PRODUCT TYPE LEAD. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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 A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT X-RAYS WERE PERFORMED AND THE PHYSICIAN WAS GIVEN THE RESULTS AND IT WAS DETERMINED THE 0-4 LEAD WAS NO LONGER FUNCTIONING. THE REP DISCUSSED WITH THE PHYSICIAN OPTIONS FOR REPLACEMENTS BASED ON INVENTORY. THE REP REPORTED THAT PROGRAMMING WAS ALSO ADJUSTED ON THE FUNCTIONING LEAD TO PROVIDE RELIEF. THE REP NOTED THAT THE PATIENT WAS CURRENTLY SPEAKING WITH HER INSURANCE COMPANY ABOUT COVERAGE FOR REPLACEMENT. NO FURTHER COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE 0-4 NO LONGER BEING FUNCTIONAL WAS UNDETERMINED. THE REP REPORTED THAT THERE WAS SPECULATION THAT THE LEADS WERE ¿OLDER AND REPLACEMENT MAY BE NEEDED.¿ THE REP NOTED THAT THE LEADS WERE IMPLANTED IN 2010 AND 2012 AND THE EXTENSIONS IN 2005. THE REP CONFIRMED THAT NO TRAUMAS OR CALLS THAT COULD HAVE AFFECTED THE IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-45, LOT# V974727, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID: 3888-33, LOT# V542025, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3888-45, SERIAL/LOT #: (B)(4), UBD: 22-MAR-2016, PRODUCT ID: 3888-33, SERIAL/LOT #: (B)(4), UBD: 09-SEP-2014, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A CORRECTION WAS MADE TO REFLECT THE MOST ACCURATE INFORMATION. THIS EVENT IS BOTH A PRODUCT AND ADVERSE EVENT. 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.
INFORMATION WAS RECEIVED FROM THE CONSUMER VIA MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION - NONMALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT HAD LESS RELIEF AND PAIN COVERAGE FROM STIMULATOR THAN NORMAL. PATIENT STATED SHE FELT SURGING AT RANDOM TIMES AND AN IRRITATING SHORT PULSE BUZZING WHEN HER STIMULATOR WAS IN USE. STIMULATOR WAS PLACED IN PERIPHERAL REGION TO TARGET HEADACHES AND MIGRAINES. PATIENT REPORTED NO CHANGES WITH HER BODY OR FALLS. HOWEVER, INCREASED HEADACHES AND HAD BEEN EXPERIENCING THE SURGES SINCE (B)(6) 2019. REP CHANGED PATIENT CONTROLLER BATTERIES, ALTERED PREVIOUS PROGRAMMING AND CHECKED FOR IMPEDANCE IN GROUP USAGE AND FOR LEADS. THERE WERE HIGH IMPEDANCES IN 0-4 LEAD. X-RAYS REQUESTED AND DISCUSSION WITH HCP ABOUT REPLACEMENT OPTIONS IF REQUIRED. THE SHORT PULSING SENSATION WAS RESOLVED WHEN ALTERING PROGRAMMING AND SOME MEDIAL COVERAGE REQUESTED WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THE TECHNICIAN PROGRAMMED THE DEVICE AROUND THE IMPEDANCE PARAMETERS TO PROVIDE THERAPY. THE DETAILS OF THE IMPEDANCES WERE PROVIDED. CURRENTLY, THE DATE IS UNKNOWN FOR FURTHER ACTION. X-RAYS WERE ORDERED BY THE PHYSICIAN TO VISUALIZE THE PLACEMENT OF LEADS AND DETERMINE NEXT STEPS. THE CAUSE WAS UNKNOWN. PATIENT REPORTED NO TRAUMA OR FALLS. THE IMPEDANCE IS PRESENT BUT PROGRAMMING WAS STRUCTURED AROUND THE AFFECTED ELECTRODES TO PROVIDE PATIENT WITH RELIEF. THE PROVIDED INFORMATION WAS CONFIRMED WITH THE PHYSICIAN/ACCOUNT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500951 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97712 | 00643169109506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | SEE H10. |