FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 814295
·
Received February 7, 2007
Report
- Report Number
- 2182207-2007-00440
- Event Type
- Injury
- Date Received
- February 7, 2007
- Report Date
- March 10, 2006
- Manufacturer
- MEDTRONIC, INC., NEUROLOGICAL DIVISION
- Product Code
- LKK
- PMA / PMN Number
- p860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DR. "A PROSPECTIVE, OPEN-LABEL STUDY OF LONG-TERM INTRATHECAL ZICONOTIDE FOR CHRONIC NONMALIGNANT BACK PAIN: A CASE REPORT". NEUROMODULATION, VOLUME 9, NUMBER 1, 2006 68-71. PATIENT EXPERIENCED INCREASED PAIN AFTER DRUG DELIVERY WAS DISCONTINUED FOR FIVE DAYS AROUND TIME OF NEW PUMP IMPLANT. IN 1998, THE PATIENT UNDERWENT PUMP POCKET REVISION SURGERY TO REDUCE THE FLUID THAT WAS SURROUNDING THE PUMP REFERENCE MFR REPORT # 2182207200700419.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | LKK | MEDTRONIC, INC., NEUROLOGICAL DIVISION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | CATHETER MODEL 8703 LOT# UNK IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT#UNK IMPLANTED:| EXPLANTED: |