FDA Adverse Event
Malfunction
Summary report: N
INTELLIS
MDR report key: 9637809
·
Received January 28, 2020
Report
- Report Number
- 3004209178-2020-01998
- Event Type
- Malfunction
- Date Received
- January 28, 2020
- Date of Event
- January 13, 2020
- Report Date
- January 28, 2020
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169781702
- 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: 3487A-33, LOT#: V002352, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REP REPORTED THAT ELECTRODES 11 AND 14 WERE OUT WHEN THE LEAD WAS CONNECTED TO THE NEW BATTERY DURING IMPLANT. THE REP REPORTED THAT IMPEDANCES WERE READ AND BOTH ELECTRODES READ THAT THERE MAY BE A SHORT. THE REP NOTED THAT THE PROVIDER WAS NOTIFIED AND SAID WE COULD PROGRAM AROUND THE ELECTRODES. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101557 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00643169781702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |