FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2032444
·
Received March 25, 2011
Report
- Report Number
- 3007566237-2011-02286
- Event Type
- Injury
- Date Received
- March 25, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PHYSICIAN REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL AND HE NEEDED TO SHUT HIS PUMP OFF. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |