FDA Adverse Event
Malfunction
Summary report: N
INDURA
MDR report key: 1052531
·
Received May 22, 2008
Report
- Report Number
- 2182207-2008-02746
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 26, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS REPLACED PROPHYLACTICALLY. UPON REMOVAL OF THE PUMP, IT WAS NOTED THAT THE CATHETER HAD A BREAK, TEAR OR HOLE. THE DEVICES WERE REPLACED. THE PUMP CONTAINED MORPHINE 50 MG/ML AT A DOSE OF 24 MG/DAY. FINAL PATIENT OUTCOME WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA | LKK | MEDTRONIC NEUROMODULATION | 8703W | L52363 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | PUMP MODEL #8627-18| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER |