FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 1801166
·
Received August 11, 2010
Report
- Report Number
- 3007566237-2010-06039
- Event Type
- Injury
- Date Received
- August 11, 2010
- Report Date
- July 13, 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)
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD A CHANGE IN THERAPY EFFECT. AFTER AN IMPLANT, PT WENT HOME AND WOKE UP WITH A HEADACHE AND EXTREME BACK PAIN AT THE CATHETER SITE AS WELL AS BILATERAL LEG PAIN IN THE MIDDLE OF THE NIGHT. THE PUMP WAS FILLED WITH BUPIVICAINE AFTER A NEW IMPLANT. THE PT IS SCHEDULED TO HAVE MRI. DRUG DOSAGE OR PRIME VOLUME TO FILL PUMP TUBING AND CATHETER WERE UNK. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE MADE AS A FOLLOW-UP AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT # UNK |