FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1782803
·
Received July 28, 2010
Report
- Report Number
- 3007566237-2010-05802
- Event Type
- Injury
- Date Received
- July 28, 2010
- Report Date
- June 30, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED PATIENT HAD UNSPECIFIED SYMPTOMS AND PROBLEMS WITH HER PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE. FOR THIRD IMPLANT REFER TO MFR REPORT # 3004209178-2010-05803. FOR FIRST IMPLANT REFER TO MFR REPORT # 6000030-2010-05801.
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 | 36 YR | Required Intervention | EXPLANTED:| IMPLANTED:| LOT# NGH037306R| IMPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8627L18| IMPLANTED:| CATHETER: MODEL 8709, LOT# N079130034| EXPLANTED:| CATHETER: MODEL 8731, LOT# B005539N19| IMPLANTABLE INFUSION PUMP: MODEL 863720| IMPLANTED:| LOT# NGP306119H| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N209302013| EXPLANTED: |