FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1901989
·
Received November 12, 2010
Report
- Report Number
- 3007566237-2010-09391
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 28, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- 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 THAT THE PT EXPERIENCED A RETURN OF PAIN SYMPTOMS. IT WAS STATED THE PT WAS HAVING "SPIKES IN PAIN THROUGHOUT THE DAY." NO RESERVOIR DISCREPANCIES WERE NOTED. A DYE STUDY WAS PERFORMED AND SHOWED NO PROBLEMS. THE PT'S CATHETER WAS SUBSEQUENTLY REVISED. THE DETAILS OF THE REVISION AND A PT OUTCOME WERE NOT REPORTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE 10 MG/ML AT 2 MG/DAY. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK |