FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1000043
·
Received February 15, 2008
Report
- Report Number
- 2182207-2008-00722
- Event Type
- Injury
- Date Received
- February 15, 2008
- Date of Event
- January 1, 2008
- Report Date
- January 16, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S NEW PUMP WAS PROGRAMMED WITH THE SAME CONCENTRATION AND DOSE AS THE OLD PUMP; HOWEVER, POST PUMP REPLACEMENT, THE PT EXPERIENCED COGNITIVE SYMPTOMS, SOMNOLENCE, WEAKNESS, HALLUCINATIONS, DELUSIONS, AND DISORIENTATION. ALL WERE ATTRIBUTED TO THE PT RECEIVING TOO MUCH MEDICATION FOLLOWING THE REPLACEMENT. THE PUMP DOSE OF DILAUDID WAS TITRATED DOWN SEVERAL TIMES FROM 4.5 MG/DAY TO 3.0MG/DAY AND THE PT'S SYMPTOMS CAME UNDER CONTROL. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention | PROGRAMMER MODEL 8840 LOT#UNK| IMPLANTED| EXPLANTED| IMPLANTED| CATHETER MODEL 8709 LOT # L57664| IMPLANTED| EXPLANTED| ACCESSORY MODEL 8578 LOT N129590| EXPLANTED |