FDA Adverse Event
Malfunction
Summary report: N
SYNCRHOMED II
MDR report key: 1071729
·
Received July 9, 2008
Report
- Report Number
- 2182207-2008-03867
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- June 1, 2008
- Report Date
- November 5, 2025
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- K860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED INCREASED PAIN AND OVERALL INEFFECTIVENESS. THE LAST REFILL WAS IN 2008, AND AT THAT TIME, THE PUMP CONTAINED DILAUDID, COMPOUNDED BACLOFEN AND CLONIDINE. ADDITIONAL DEVICE TROUBLESHOOTING WAS BEING CONSIDERED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCRHOMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | Required Intervention | CATHETER: MODEL 8596| CATHETER: MODEL 8598| CATHETER: MODEL 8731| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840| EXPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8731| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8598| IMPLANTED:| CATHETER: MODEL 8596 |