FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1895477
·
Received November 5, 2010
Report
- Report Number
- 3004209178-2010-08940
- Event Type
- Injury
- Date Received
- November 5, 2010
- Date of Event
- September 1, 2010
- Report Date
- October 15, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CATHETER HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT'S CATHETER FRACTURED AFTER IMPLANT. IT WAS STATED THE PT WAS RECEIVING A "SUB-THERAPEUTIC DOSE" OF MEDICATION, BUT NO SPECIFIC SYMPTOMS WERE REPORTED. THE FRACTURED SEGMENT OF THE CATHETER WAS SUCCESSFULLY REPLACED, BUT NO PT OUTCOME WAS REPORTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL. 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 | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8583, LOT# B0924523K| CATHETER: MODEL 8731SC, LOT #B0882541K| IMPLANTED:| EXPLANTED: |