FDA Adverse Event
Injury
Summary report: N
MEDTRONIC INSULIN PUMP
MDR report key: 3221766
·
Received July 9, 2013
Report
- Report Number
- MW5030832
- Event Type
- Injury
- Date Received
- July 9, 2013
- Report Date
- July 9, 2013
- Manufacturer
- MEDTRONIC
- Product Code
- LZG
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CALLER HAS BEEN USING INSULIN PUMPS FOR ABOUT 5 YRS. STOPPED USING THEM ON (B)(6) 2013 DUE TO CONTINUOUS PAIN FOR 4 WEEKS. RECENTLY GOT A LETTER THAT THESE PUMPS HAVE BEEN RECALLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312408 | MEDTRONIC INSULIN PUMP | MEDTRONIC INSULIN PUMP RESERVOIR | LZG | MEDTRONIC | H8521052 | ||
| 312409 | MEDTRONIC INSULIN PUMP | MEDTRONIC INSULIN PUMP RESERVOIR | LZG | MEDTRONIC | H8603292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |