SURESCAN
Report
- Report Number
- 3004209178-2014-13268
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 27, 2014
- Report Date
- August 15, 2016
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- GZB
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).
THE IMPLANT WAS NOT WORKING AT ALL AND THE PATIENT DID NOT FEEL ANY STIMULATION. THE PATIENT HAS NEVER CHARGED THE IMPLANT SINCE SHE GOT IT PUT IN, SHE NEEDED ASSISTANCE CHARGING. HOW TO CHARGE WAS REVIEWED. THE PATIENT WAS GOING TO CHARGE AND ONCE THE IMPLANT IS CHARGED AND ON SHE WAS GOING TO CALL BACK FOR FURTHER ASSISTANCE. THE PATIENT FELT THAT SHE NEEDED TO MAKE ADJUSTMENTS IN PROGRAMMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. IT WAS REPORTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2016-AUG-04 WITH THEIR HEALTHCARE PROVIDER (HCP) TO DISCUSS INS OVERDISCHARGE NEEDS AND NEXT STEPS. FOLLOW-UP HAS BEEN CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421966 | SURESCAN | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | GZB | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR |