SURESCAN
Report
- Report Number
- 3004209178-2016-05230
- Event Type
- Injury
- Date Received
- March 23, 2016
- Report Date
- July 9, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3986A, LOT # N064919, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT # N072806, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD.
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.
A COMPANY REPRESENTATIVE (REP) REPORTED ON 2016-02-26 THAT THEY WERE NOTIFIED BY A HEALTH CARE PROVIDER (HCP) THE PREVIOUS DAY THAT ONE OF THE PATIENT'S LEAD IMPEDANCES WERE OUT. IT WAS NOTED THAT THE IMPEDANCES WERE FINE IN (B)(6) 2015, WHEN THE PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT. THERE WERE NO RELATED PATIENT SYMPTOMS REPORTED, AND THE INDICATION FOR USE WAS SPINAL PAIN. THE REP PROVIDED ADDITIONAL INFORMATION ON 2016-03-03 STATING THAT THE PATIENT WAS IN THE PROCESS OF SCHEDULING A LEAD REVISION, AND THE CAUSE OF THE IMPEDANCE ISSUE WAS STILL UNKNOWN.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT ATTEMPTED TO USE THE DEVICE FOR ABOUT 12 MONTHS BUT ONLY HALF OF IT WORKED DUE TO THE BROKEN LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175387 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |