FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2191789
·
Received July 22, 2011
Report
- Report Number
- 3007566237-2011-05701
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 2, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT UNDERWENT A SCHEDULED PUMP REPLACEMENT. DURING THE REPLACEMENT SURGERY, THE CATHETER WAS EVALUATED BY ATTEMPTING TO ASPIRATE FROM THE CATHETER ACCESS PORT WITHOUT SUCCESS. FLUID COULD NOT BE WITHDRAWN, SO THE CATHETER WAS REPLACED. THE MANAGING PHYSICIAN BELIEVED THE CATHETER HAD BEEN FUNCTIONING PROPERLY; THERE WERE NO APPARENT WITHDRAWAL SYMPTOMS PRIOR TO SURGERY. THE DEVICE USED TO DELIVER LIORESAL 2000 MCG/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Required Intervention | EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # J12331R35| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N231138013| LOT # NGP356096H| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-20,| PROGRAMMER: MODEL 8840, LOT # UNK |