FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 2041414
·
Received March 24, 2011
Report
- Report Number
- 3007566237-2011-02250
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 25, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE ACTUAL RESIDUAL PUMP VOLUME (12CC) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (4CC). 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 EL | LKK | MEDTRONIC NEUROMODULATION | 8627 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |