SURESCAN
Report
- Report Number
- 3004209178-2017-26636
- Event Type
- Injury
- Date Received
- December 26, 2017
- Date of Event
- December 21, 2017
- Report Date
- April 18, 2018
- 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
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(PMA/510K): CORRECTED FROM P960009 TO P840001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT WANTED TO MOVE THEIR BATTERY FOR AID IN THEIR COMFORT. NO CONTRIBUTING FACTORS WERE KNOWN. MULTIPLE RECHARGERS WERE USED TO TEST THEIR COUPLING BARS. THE PHYSICIAN WASN'T HAPPY WITH THE RESULTS OF THE RECHARGING AND WANTED A NEW BATTERY. THE BATTERY WAS REPLACED. THE PATIENT WAS HAVING A POCKET REVISION WHEN THIS OCCURRED. INCONSISTENT COUPLING BARS WERE NOTED. THE COUPLING RANGED FROM 0 TO 8 BARS AND GOT THESE RESULTS EVEN WHEN THE BATTERY WAS OUTSIDE OF THE BODY. THE IMPEDANCES WERE GREAT AND THE LEAD WAS STILL CONNECTED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
THE PATIENT WAS IMPLANTED FOR NON-MALIGNANT PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 925006 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |