FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2871765
·
Received December 13, 2012
Report
- Report Number
- 3007566237-2012-03002
- Event Type
- Malfunction
- Date Received
- December 13, 2012
- Report Date
- November 13, 2012
- 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED INCREASED PAIN AFTER BEING TASERED AT WORK. IT WAS NOTED THE PATIENT RECEIVED THE TASE IN HIS HAND FOR FIVE SECONDS WITH 50,000 VOLTS THROUGH HIS WHOLE BODY. THE PATIENT FELL AND "LANDED LIKE A ROCK," ON HIS KNEES AND "JAMMED" HIS HIP WHICH HISTORICALLY CAUSED PAIN. IT WAS NOTED THE ACUTE PAIN DID NOT START IMMEDIATELY AFTER FALL, BUT STARTED LATER IN THE EVENING. IT WAS UNCLEAR IF THE PAIN WAS FROM THE FALL OR IF "SOMETHING HAPPENED TO THE PUMP" DURING THE FALL. THE DEVICE SYSTEM WAS USED TO INFUSE MORPHINE. 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 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |