FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1940359
·
Received December 20, 2010
Report
- Report Number
- 3007566237-2010-10603
- Event Type
- Injury
- Date Received
- December 20, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 8, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT WAS HOSPITALIZED BECAUSE "SOMETHING HAPPENED." IT WAS UNK IF AN MRI WAS TOO STRONG OR IF THE PUMP HAD STOPPED. THE DATE OF THE MRI WAS NOT PROVIDED. NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 | 58 YR | Hospitalization | IMPLANTED:| CATHETER: MODEL 8709, LOT #: J12207R06| EXPLANTED: |