FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2011501
·
Received March 7, 2011
Report
- Report Number
- 3007566237-2011-01678
- Event Type
- Injury
- Date Received
- March 7, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 15, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS ALONG WITH INCREASED PAIN OVER THE PAST 2 MONTHS. THE PATIENT'S PUMP WAS REPLACED. DURING THE PUMP REPLACEMENT PROCEDURE, THE PHYSICIAN WAS UNABLE TO ASPIRATE THE CATHETER, SO THE ENTIRE CATHETER WAS REPLACED. UPON REMOVAL OF THE CATHETER, THERE WAS A PRECIPITATE NOTED ON THE CATHETER TIP. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11901R02 |