FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 2050051
·
Received March 31, 2011
Report
- Report Number
- 3004209178-2011-02468
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Report Date
- March 14, 2011
- Manufacturer
- MEDTRONIC 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
SEE MANUFACTURE REPORT # 3004209178201102466. THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION FOLLOWING EXPOSURE FROM A SECURITY GATE (B)(6). THE DEVICE WAS ON DURING EXPOSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTABLE NEURO STIMULATOR: MODEL 7425,| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU155892V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU077190V| EXPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL025382P| LEAD: MODEL 3986A, LOT# N124613| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434A, LOT# NGL031981P| IMPLANTED:| LOT# NAT152011H| LEAD: MODEL 3487A, LOT# J0527428V |