FDA Adverse Event
Malfunction
Summary report: N
SURESCAN
MDR report key: 3821639
·
Received May 20, 2014
Report
- Report Number
- 3004209178-2014-09294
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 28, 2014
- Report Date
- June 20, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER AN NEUROSTIMULATOR CHANGE OUT, IMPEDANCES WITH THE NEW INS WERE NORMAL EXCEPT THOSE PAIRS WITH #7, WHICH WERE HIGH. IN ADDITION, POST OPERATIVELY, THEY COULD NOT GET ANY TELEMETRY EVEN THOUGH THEY HAD TELEMETRY INTRAOPERATIVE. NEW BATTERIES WERE ADVISED. IT WAS FURTHER STATED THAT THE PROGRAMMER BATTERIES WERE LOW AND WERE REPLACED. ALL WAS GOOD AFTER THAT. THE PATIENT WAS NOTED TO HAVE GOOD COVERAGE AS WELL.
Description of Event or Problem · 1
IT WAS FURTHER REPORTED THAT THE HIGH IMPEDANCES RESOLVED SEVERAL HOURS AFTER IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300789 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |