FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1211068
·
Received October 24, 2008
Report
- Report Number
- 2182207-2008-06871
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 25, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT DEVELOPED AN INFECTION FOLLOWING A PUMP REPLACEMENT SURGERY. THE DRUG USED IN THE PUMP IS LIORESAL 2000 MCG/ML WITH MORPHINE AND BUPIVICAINE (NO CONCENTRATIONS REPORTED). THE PRIMARY DRUG IS LIORESAL AT A DOSE OF 875 MCG/DAY. THE PT IS A SPINAL CORD INJURY PARAPELGIC. THE PHYSICIAN WAS TITRATING THE IT BACLOFEN DOSE DOWN FOR EXPLANT OF THE PUMP. NO PT SYMPTOMS WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | CATHETER MODEL CATHETER| PROGRAMMER MODEL 8840| IMPLANTED:| EXPLANTED: |