FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 2013491
·
Received February 3, 2011
Report
- Report Number
- 3004209178-2011-00869
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- November 1, 2010
- Report Date
- January 19, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE IMPLANTABLE NEUROSTIMULATOR WAS REPROGRAMMED BY A FIELD REP IN (B)(6) 2010. THE PT WENT HOME AND TURNED STIMULATION OFF. SINCE THEN, HE WAS NOT ABLE TO TURN STIMULATION BACK ON. THE PT WAS SEEN BY THE FIELD REP APPROXIMATELY 2 MONTHS LATER. THE IMPLANTABLE NEUROSTIMULATOR WAS IN A POWER ON RESET CONDITION. ONCE THE POWER ON RESET WAS CLEARED, THE PT STARTED TO FEEL STIMULATION, BUT STATED IT FELT LIKE A SHOCKING SENSATION. THE BATTERY VOLTAGE WAS OK. THE HCP PLANNED TO REPLACE THE IMPLANTABLE NEUROSTIMULATOR AND CHECK CONNECTIONS DURING REVISION SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | PROGRAMMER: MODEL 7434A, LOT# NGL031798P| EXPLANTED:| EXTENSION: MODEL 7482, LOT #NHU118817V| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3587A, LOT# N075410 |