SYNCHROMED II
Report
- Report Number
- 3004209178-2011-03938
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 2, 2011
- 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
- NV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
(B)(4).
(B)(4).
IT WAS REPORTED THAT THE PT'S CATHETER HAD COMPLICATIONS. THE CATHETER WAS NOT IMPLANTED CORRECTLY INTO THE INTRATHECAL SPACE. THE PT WAS ALWAYS PROGRAMMED AT THE HIGHEST DOSAGE OF MEDICATION AND WAS "POISONED BY THE MEDICATION" BECAUSE IT WAS NOT GOING INTO THE INTRATHECAL SPACE. THE PT'S PUMP AND CATHETER WERE REMOVED. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS UNK. ADDITIONAL INFO HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT HAD "5 MEDS GOING THROUGH THE PUMP AND HAD IT ON THE HIGHEST SETTINGS" BUT IT DID NOT HELP HER PAIN. SPECIFIC MEDICATIONS WERE NOT PROVIDED. THE PATIENT HAD THE PHYSICIAN LOOK INTO IT AND STATED THAT THE PHYSICIAN DID NOT PROPERLY INSTALL THE CATHETER. AFTER THE PUMP AND CATHETER WERE EXPLANTED THE PATIENT HAD A DIFFERENT DEVICE IMPLANTED AND HAS HAD NO ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT: N073959030 |