SURESCAN
Report
- Report Number
- 3004209178-2018-20435
- Event Type
- Injury
- Date Received
- September 12, 2018
- Date of Event
- August 27, 2018
- Report Date
- July 3, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169109483
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
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.
PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2019. PRODUCT TYPE LEAD, PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2019. PRODUCT TYPE LEAD. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALIES. ANALYSIS OF THE LEADS FOUND THAT THE LEAD CONDUCTOR WAS BROKEN AT THE ANCHOR SITE. 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.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260 , SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT WAS NO LONGER FEELING STIMULATION AS OF APPROXIMATELY TWO WEEKS PRIOR TO THE CALL. AN IMPEDANCE CHECK WAS RAN AND MULTIPLE CONTACTS HAD HIGH IMPEDANCES OF > 10000 OHMS. THE FOLLOWING DATA WAS REPORTED: 0 813 1 --- 2 1295 3 2445 4 >10000 5 >10000 6 >10000 7 >10000 8 1035 9 >10000 10 >10000 11 >10000 12 >10000 13 1390 14 >10000 15 977 REPROGRAMMING WAS PERFORMED AND THE PATIENT REPORTED HAVING BILATERAL, EQUAL TINGLING. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. NO FURTHER COMPLICATIONS ARE ANTICIPATED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING THE PATIENT. IT WAS REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCES WERE UNABLE TO BE DETERMINED, AND THE PATIENT¿S WEIGHT WAS UNKNOWN. ON 09/10/2018 WOULD HAVE BEEN THE FIRST TIME THAT THE PATIENT AND MANUFACTURER REPRESENTATIVE KNEW OF THE HIGH IMPEDANCES. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP). THE REP REPORTED THAT IMPEDANCES WERE CHECKED AGAIN ON THE DAY OF THE REPORT, AND ALL ELECTRODES WERE OUT OF RANGE. THEY NOTED THAT THE PATIENT DID NOT HAVE ANY TRAUMA. THEY ALSO INDICATED THAT A FLUOROSCOPY SHOWED THAT THE LEAD DIDN'T MOVE IN THE EPIDURAL SPACE, AND IT DOESN'T APPEAR THAT THE LEAD WAS PULLED OUT OF THE INS HEADER BLOCK. THE REP DISCUSSED CHECKING THE LEAD WITH A WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) WHEN A REVISION OCCURS. IF THE LEAD IS FINE, A CONNECTION ISSUE WITH THE HEADER BLOCK IS SUSPECTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.
ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REVISION/REPLACEMENT WAS SCHEDULED FOR (B)(6) 2019. ALL ELECTRODE IMPEDANCES WERE OUT OF RANGE. THE HCP REPLACED BOTH LEADS AND THE INS. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 711247 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |