FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2230767
·
Received August 23, 2011
Report
- Report Number
- 3007566237-2011-06711
- Event Type
- Injury
- Date Received
- August 23, 2011
- Report Date
- July 29, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z # 1151-2008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN INFLAMMATORY MASS WAS REPORTED. PATIENT DEVELOPED GRANULOMA AT T-12, L-1. IT WAS DISSECTED AND OLD CATHETER WAS COMPLETELY REMOVED. IT WAS AN 8MM GRANULOMA "INTERTWINED IN NEURO FIBERS", HENCE COULD NOT BE REMOVED ENTIRELY. THE PUMP AND THE CATHETER WERE REPLACED. THE NEW CATHETER TIP WAS LOCATED AT BOTTOM OF L-2. THE DRUG INFUSED WAS DILAUDID 30 MG/ML AT 1.44 MG/DAY. PATIENT WAS REFEREED TO PAIN CLINIC AND THEY WERE PLANNING ON REDUCING DRUG CONCENTRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| R | CATHETER: MODEL 8709, LOT# J12276R07.| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J12276R07| IMPLANTED: |