FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2963840
·
Received February 15, 2013
Report
- Report Number
- 3007566237-2013-00503
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- January 17, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2006. PRODUCT TYPE: CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE A SUTURE AROUND THE CATHETER WHERE IT MET THE PUMP. NO FLOW HAD BEEN SEEN DURING A DIAGNOSTIC FLUOROSCOPY TEST. IT WAS REPORTED THAT THE EVENT WAS RESOLVED WITHOUT SEQUELA. ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT THE CATHETER HAD BEEN OCCLUDED BY THE SUTURE, THOUGH NO CATHETER REPLACEMENT WAS NECESSARY AS A RESULT OF THIS EVENT. THE DRUG USED IN THIS SYSTEM WAS INFUMORPH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67041 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |