FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1822432
·
Received August 26, 2010
Report
- Report Number
- 3007566237-2010-06490
- Event Type
- Injury
- Date Received
- August 26, 2010
- Report Date
- July 26, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4): 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
THE PUMP AND CATHETER WERE EXPLANTED AND NOT REPLACED DUE TO INFECTION. SPECIFIC PT SYMPTOMS OF INFECTION AND DATE OF ONSET OF INFECTION WERE NOT REPORTED. THE PUMP DELIVERED MORPHINE 10 MG/ML AT 2 MG/DAY. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER: MODEL 8709SC, LOT# J12170R15| EXPLANTED:| IMPLANTED: |