FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1972418
·
Received January 24, 2011
Report
- Report Number
- 3007566237-2011-00557
- Event Type
- Injury
- Date Received
- January 24, 2011
- Date of Event
- January 8, 2011
- Report Date
- January 12, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED AN UNDERDOSE. THE PUMP WAS REFILED ON (B)(6) 2011 AND THE PT REMAINED HOSPITALIZED FOR TESTS. THEY FOUND THE CATHETER WAS LEAKING A SMALL AMOUNT. THEY GAVE THE PATIENT A MORPHINE BOLUS. THE PATIENT WAS NOT DOING BETTER. A PUMP AND CATHETER REPLACEMENT WAS PLANNED. THE DEVICE SYSTEM WAS USED TO DELIVERY MORPHINE. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L 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 | Hospitalization | CATHETER: MODEL 8731, LOT# B0403279K| IMPLANTED:| EXPLANTED: |