FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1884637
·
Received October 19, 2010
Report
- Report Number
- 3007566237-2010-08084
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 1, 2010
- Report Date
- September 21, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- 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, PT HAD A PUMP REPLACEMENT. PT AND PHYSICIAN HAD DISCUSSED THE OPTIONS AND PT HAD ELECTED A PUMP REPLACEMENT DUE TO THE SIZE OF CURRENT PUMP AND DISCOMFORT ASSOCIATED WITH THE SIZE OF THE 40CC PUMP. IT WAS NOTED GOOD PAIN MANAGEMENT WITH CURRENT AND PAST PUMP. IT WAS LATER REPORTED THAT 25MG/CC DILAUDID WITH 25UG/CC. TEN MG/DAY WAS BEING USED IN PT'S PUMP. PHYSICIAN'S OFFICE STATED PT HAD RECOVERED FROM REPLACEMENT AND WAS DOING WELL. ADDITIONAL INFORMATION WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.
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 | Required Intervention | CATHETER: MODEL 8731, LOT# N001860528| EXPLANTED:| IMPLANTED: |