FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 4093259
·
Received September 16, 2014
Report
- Report Number
- 3004209178-2014-17107
- Event Type
- Injury
- Date Received
- September 16, 2014
- Report Date
- August 26, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
FOLLOWING A PUMP AND CATHETER REVISION (SEE MANUFACTURER¿S REPORT # 3004209178-2014-17105), THE PATIENT STARTED HAVING SEVERE HEADACHES. THEY WERE PLANNING TO DO A BLOOD PATCH, AND THEY CONFIRMED THAT THEY FEEL THE HEADACHES WERE DUE TO A CEREBROSPINAL FLUID (CSF) LEAK. THE PATIENT¿S HEALTHCARE PROVIDER (HCP) WANTED TO INCREASE THE PATIENT¿S DOSE. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE THE CAUSE OF THE CSF LEAK, THE PATIENT¿S SYMPTOMS, AND THE PATIENT¿S OUTCOME. THE PUMP CONTAINED BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571405 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Required Intervention |