FDA Adverse Event
Injury
Summary report: N
SYNCRHOMED II
MDR report key: 2160819
·
Received July 7, 2011
Report
- Report Number
- 3007566237-2011-05196
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 16, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT INITIALLY WAS REPORTED THAT A CATHETER REPLACEMENT WAS PLANNED DUE TO A POSSIBLE KINK OR OCCLUSION. THE PT HAD BEEN EXPERIENCING A LOSS OF THERAPEUTIC EFFECT AND WITHDRAWAL SYMPTOMS. IT LATER WAS REPORTED THAT THE HEALTH CARE PROVIDER (HCP) DID NOT PERFORM A REVISION, BUT PROGRAMMED A BOLUS INTO THE PUMP AND THE PT WAS DOING FINE. THE HCP WAS UNCERTAIN AS TO WHETHER THERE WAS AN ISSUE WITH THE CATHETER. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT WHEN ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCRHOMED II | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT# N187055002 |