FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1870736
·
Received October 12, 2010
Report
- Report Number
- 6000030-2010-07865
- Event Type
- Injury
- Date Received
- October 12, 2010
- Date of Event
- February 6, 2006
- Report Date
- June 11, 2010
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FINAL ANALYSIS - FINAL DEVICE ANALYSIS OF THE PUMP SHOWED NO ANOMALIES. THE CATHETER WAS NOT RETURNED. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT DURING SURGERY, THE CATHETER WAS ALSO OBSERVED TO BE CORRODED ALONG WITH A KINK THAT WAS PREVIOUSLY REPORTED. IT WAS ALSO NOTED THAT PATIENT HAD NO SIGNS AND SYMPTOMS. PATIENT OUTCOME WAS NOTED AS RESOLVED WITHOUT SEQUELA AS OF (B)(6) 2006.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS REPLACED FOR SUSPECTED BATTERY DEPLETION. A KINK IN THE CATHETER WAS FOUND AT THE PROXIMAL PORTION OF THE CATHETER, WHICH WAS REVISED. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE MORPHINE SULFATE, BUPIVICAINE, AND CLONIDINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8703W, LOT# L53970| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK |