FDA Adverse Event
Injury
Summary report: N
XMTR MMT-7703NA MINILINK GST1 17L REPL
MDR report key: 1870128
·
Received October 11, 2010
Report
- Report Number
- 2032227-2010-82908
- Event Type
- Injury
- Date Received
- October 11, 2010
- Date of Event
- September 23, 2010
- Report Date
- September 23, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE MINILINK WAS UNABLE TO CHARGE DUE TO A SWOLLEN AND DEPLETED BATTERY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR SEIZURES DUE TO HIGH AND LOW BLOOD GLUCOSE LEVELS. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS ARE ERRATIC DUE TO PANCREATIC FAILURE. THE CUSTOMER ALSO REPORTED THAT THE MINILINK IS NO LONGER CHARGING. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XMTR MMT-7703NA MINILINK GST1 17L REPL | TRANSMITTER | MDS | MEDTRONIC MINIMED | MMT-7703NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization |