FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1864490
·
Received October 6, 2010
Report
- Report Number
- 3007566237-2010-07650
- Event Type
- Injury
- Date Received
- October 6, 2010
- Date of Event
- August 17, 2010
- Report Date
- August 17, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP AND THE PUMP SECTION OF THE CATHETER WERE EXPLANTED DUE TO AN INFECTION IN THE PUMP POCKET. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS DILAUDID. THE PATIENT WAS NOT INJURED AND RECOVERED WITHOUT SEQUELA. 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 | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention | IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N153847023| EXPLANTED: |