SYNCHROMED II
Report
- Report Number
- 3007566237-2013-00430
- Event Type
- Injury
- Date Received
- February 8, 2013
- Report Date
- January 22, 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
PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).
(B)(4).
IT WAS REPORTED THAT THERE WAS SUSPICION OF GRANULOMA FORMATION IN THE EPIDURAL SPACE IN RESPONSE TO MORPHINE. AN MRI OF THE THORACIC SPINE WAS PERFORMED ON (B)(6) 2011, HOWEVER, THE RESULTS WERE NOT PROVIDED. IT WAS REPORTED THE DIAGNOSTIC METHODS INCLUDED DEVICE INTERROGATION. THE PATIENT EXPERIENCED LEFT ARM WEAKNESS, PARESTHESIA, AND MILD CHEST WALL NUMBNESS. IT WAS NOTED THE OUTCOME WAS DETERMINED TO BE AN ONGOING EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE AND CLONIDINE. IT WAS LATER REPORTED AFTER THE PATIENT HAD THE MRI, SHE RETURNED TO THE CLINIC TO HAVE HER INTRATHECAL THERAPY SUSPENDED AND THE DRUG IN THE PUMP WAS REPLACED WITH STERILE SALINE ON (B)(6) 2011. IT WAS REPORTED THE MRI WITHOUT CONTRAST REVEALED A CATHETER TIP GRANULOMA. IT WAS NOTED THIS WAS RELATED TO THE DRUG AND IT WAS REPORTED, "MORPHINE INDUCED GRANULOMA FORMATION." IT WAS LATER REPORTED REIMAGING OF THE SPINE, AN MRI WITH AND WITHOUT CONTRAST, SHOWED COMPLETE RESOLUTION OF THE CATHETER TIP GRANULOMA AS OF (B)(6) 2011. IT WAS REPORTED THERAPY RESUMED ON (B)(6) 2011. THE OUTCOME OF THE PATIENT WAS REPORTED TO HAVE BEEN RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55100 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00047 YR | Other |