FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 2092146
·
Received April 27, 2011
Report
- Report Number
- 3007566237-2011-03117
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 30, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- 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 PT EXPERIENCED A CHANGE IN THERAPY EFFECT. THE ACTUAL RESIDUAL PUMP VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME; THE REPORTER DID NOT PROVIDE SPECIFIC VALUES FOR THE VOLUMES. THE PT HAD AN MRI; THE REPORTER DID NOT BELIEVE ANY MOTOR STALL WAS LOGGED IN THE PUMP LOGS. 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 | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PROGRAMMER: MODEL 8835, SERIAL# UNK |