FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 3120680
·
Received May 20, 2013
Report
- Report Number
- 3007566237-2013-01679
- Event Type
- Injury
- Date Received
- May 20, 2013
- Report Date
- April 22, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8731SC, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED PAIN. THE PATIENT RETURNED TO THE HOSPITAL BECAUSE OF WITHDRAWAL SYMPTOMS. THE PHYSICIAN DURING THE CATHETER REVISION FOUND AN OCCLUSION NEAR THE CATHETER TIP AND SOLID BLACK MATERIAL IN THE CATHETER LUMEN. THE CATHETER WAS REPLACED. THE PATIENT WAS HOSPITALIZED. THE PATIENT STATUS WAS ALIVE, NO INJURY, NO ADVERSE EVENT. THE PATIENT NOW FEELS FINE AND HE RECEIVES EFFECTIVE THERAPY. THE PUMP WAS DELIVERING ZICONOTIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222277 | SYNCHROMED | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |