SYNCHROMED II
Report
- Report Number
- 3004209178-2013-05861
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- March 13, 2013
- 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).
ANALYSIS OF THE PUMP KIT REVEALED THAT THE SC CONNECTOR HAD CORING TEARS-CUTS IN SEAL. MEETS LEAK CRITERIA PER (B)(4). ANALYSIS FOR THE PUMP REVEALED NO ANOMALY. ANALYSIS OF THE CATHETER FOUND A HOLE NEAR THE END OF THE DISTAL SEGMENT. THE CHARACTERISTICS OF THE HOLE ARE VERY TYPICAL OF A SHEAR HOLE CAUSED BY AN INTERACTION OF THE CATHETER WITH ITS GUIDEWIRE DURING THE IMPLANT PROCEDURE.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE HCP BELIEVED THAT THERE MIGHT BE SOMETHING WRONG WITH THE PUMP BECAUSE IT WAS NOT PROVIDING THERAPY. IT TURNED OUT TO BE A CATHETER BREAK AT THE DISTAL SEGMENT OF THE CATHETER. THE TOTAL SYSTEM WAS REPLACED. THE PATIENT HAD EXPERIENCED PAIN. PATIENT STATUS WAS REPORTED AS ALIVE - NO INJURY/NO ADVERSE EVENT. THE PUMP WAS USED TO DELIVER INFUMORPH. (B)(6) 2013 (RP) PRODUCT RETURN WITH NO INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152624 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |