FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 2140967
·
Received June 21, 2011
Report
- Report Number
- 6000030-2011-04624
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- May 2, 2011
- Report Date
- June 19, 2011
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AT A PUMP REFILL ON (B)(6) 2011, THE PATIENT REPORTED HAVING HAD INCREASED SPASTICITY SINCE (B)(6) 2011. THE DRUG INFUSION RATE WAS WITHIN SPECIFICATION. THE DOCTOR DECIDED TO OBSERVE THE PATIENT WITH ADMINISTRATION OF ORAL BACLOFEN. ON (B)(6) 2011, A ROTOR STUDY AND CATHETER DYE WERE DONE; THE RESULTS SHOWED NO ANOMALY. AN ABNORMAL INFUSION RATE WAS OBSERVED; THE EXPECTED RESERVOIR VOLUME WAS 11.1ML, THE ACTUAL VOLUME WAS 17ML. THE DOCTOR SUSPECTED A PUMP MALFUNCTION. THE PUMP WAS REPLACED. THE PATIENT OUTCOME WAS REPORTED AS "RECOVERED". THE DEVICE SYSTEM WAS USED TO DELIVER GABALON (BACLOFEN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention | CATHETER MODEL 8711| CATHETER: MODEL CATHETER, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNKNOWN| EXPLANTED: |