FDA Adverse Event
Other
Summary report: N
MEDTRONIC NEUROMODULATION IMPLANTED INFUSION PUMP
MDR report key: 1040332
·
Received May 9, 2008
Report
- Report Number
- MW5006782
- Event Type
- Other
- Date Received
- May 9, 2008
- Date of Event
- May 5, 2008
- Report Date
- May 6, 2008
- Product Code
- LKK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
CLIENT REPORTS INCREASED AND NEW PAIN IN BACK. IMPLANTED PUMP USED FOR BOTH MORPHINE AND BACLOFEN. REPORTS HE FELT "PUMP NOT WORKING", "SOMETHING WAS NOT RIGHT" PAST 1-2 WEEKS. CLIENT FOUND OUT HIS IMPLANTED PUMP ON RECALL LIST. PAIN SPECIALIST INCREASED "BY MOUTH MEDICATION. WAITING TO HEAR FROM DR (PUT PUMP IN) DIAGNOSIS OR REASON FOR USE: PAIN, SPASM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC NEUROMODULATION IMPLANTED INFUSION PUMP | BACLOFEN PUMP | LKK | 863740AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |