SYNCHROMED II
Report
- Report Number
- 3004209178-2014-13804
- Event Type
- Injury
- Date Received
- August 1, 2014
- Report Date
- July 10, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 8711, SERIAL# (B)(4) IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).
IT WAS REPORTED THAT THE PUMP FLIPPED , WHICH CAUSED THE CATHETER TO COIL AT THE PROXIMAL SEGMENT AND PUMP CONNECTOR. IT WAS INDICATED THAT X-RAYS WERE DONE. THE PATIENT EXPERIENCED CHRONIC PAIN IN HIS LOWER BACK. ON THE DATE OF THIS REPORT, A PUMP POCKET REVISION WAS DONE. THERE WAS ONLY 1 SUTURE, WHICH HAD BROKEN LOOSE. THE HEALTHCARE PROVIDER (HCP) PLACED 3 SUTURE TIES DOWN. HE DID NOT USE ALL 4, BUT STATED THAT 3 WAS SECURE. THE HCP ALSO REPLACED THE ENTIRE CATHETER SYSTEM DUE TO THE COILED CATHETER. THE PATIENT NOTICED INCREASED PAIN WHEN THE PUMP WAS DECREASED OR WEANED PRIOR TO THE SURGERY. AT THE TIME OF THIS REPORT, THE PATIENT STATUS WAS INDICATED TO BE ¿ALIVE-NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AND BUPIVACAINE. T WAS LATER REPORTED THAT THE CAUSE OF THE ISSUE WAS THAT THE SUTURE BROKE LOOSE AND NOT ALL 4 SUTURES WERE USED.
ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) INDICATED A CATHETER DYE STUDY WAS PERFORMED ON (B)(6) 2014 AND THE SURGICAL REPAIR TOOK PLACE ON (B)(6) 2014. THE DOSE WEANING PROCESS BEGAN ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451142 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention |