FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 2061948
·
Received April 6, 2011
Report
- Report Number
- 3004209178-2011-02635
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 21, 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
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING AN UNRELATED ABDOMINAL SURGERY. PATIENT HAD SURGERY TO REPAIR A HERNIA AND SINCE THEN HAS FELT LIKE SOMETHING WAS DISLODGED AND A LEAD HAS MOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.
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 | 65 YR | IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0010999N| LEAD: MOEDL 3888, LOT# L31712| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0014104P |