SYNCHROMED
Report
- Report Number
- 2182207-2008-05495
- Event Type
- Injury
- Date Received
- September 5, 2008
- Report Date
- August 7, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(SEE SCANNED PAGES).
LITERATURE REFERENCE:ILIAS W, LE POLAIN B, BUCHSER E, ET AL. PATIENT-CONTROLLED ANALGESIA IN CHRONIC PAIN PATIENTS: EXPERIENCE WITH A NEW DEVICE DESIGNED TO BE USED WITH IMPLANTED PROGRAMMABLE PUMPS. PAIN PRACT. 2008;8(3): 164-170. A POSSIBLE SOLUTION TO ALLEVIATION OF UNPREDICTABLE PAIN IS THE USE OF PATIENT CONTROLLED ANALGESIA BY MEANS OF THE PERSONAL THERAPY MANAGER (PTM), DESIGNED TO BE USED WITH IMPLANTED PROGRAMMABLE PUMPS. A MULTICENTER, OPEN-LABEL REGISTRY RECORDING 168 PATIENTS SUFFERING FROM CHRONIC PAIN WITH UNSATISFACTORY CONTROL OF PAIN EPISODES WAS INITIATED. WHILE 79 PATIENTS (47%) (GROUP A) ALREADY CARRIED AN IMPLANTED PUMP AT ENROLLMENT, ALL OTHER PATIENTS WERE IMPLANTED AFTER BEING REGISTERED IN THE STUDY (GROUP B). PARAMETERS ASSESSED INCLUDED PAIN RELIEF, QUALITY OF LIFE, PATIENT AND PHYSICIAN SATISFACTION, MEDICATION USE, PTM PROGRAMMING PARAMETERS AND ADVERSE EVENTS. FINAL FOLLOW-UP WAS AT 12 MONTHS. REPORTABLE EVENT: THE STUDY RECORDED 16 ADVERSE EVENTS RELATED TO THE PUMP. ELEVEN OF THE EVENTS WERE PUMP MEMORY ERRORS WHICH CAUSED THE PUMP TO STALL. THIS PROBLEM WAS RESOLVED IN ALL CASES AFTER REPROGRAMMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER MODEL UNK N=1| PTM MODEL UNK N=1| PER PATIENT - CATHETER MODEL UNK N=1 |