FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1432412
·
Received August 3, 2009
Report
- Report Number
- 3004209178-2009-05336
- Event Type
- Injury
- Date Received
- August 3, 2009
- Report Date
- July 7, 2009
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZM
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
SEE MANUFACTURER # 3004209178-2009-05335. IT WAS REPORTED THAT THE PATIENT HAD AN OPERATION TO REPOSITION THEIR DEVICE. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZM | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 3095| IMPLANTED:| EXTENSION: MODEL 3095| IMPLANTABLE PULSE GENERATOR: MODEL 3023| EXPLANTED:| LEAD: MODEL 3889| EXPLANTED:| LEAD: MODEL 3889| PROGRAMMER: MODEL 3031A| EXPLANTED:| IMPLANTED:| IMPLANTED:| LOT # NBV131427H| EXPLANTED: |