FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1844559
·
Received September 23, 2010
Report
- Report Number
- 3007566237-2010-07242
- Event Type
- Injury
- Date Received
- September 23, 2010
- Date of Event
- June 2, 2008
- Report Date
- June 11, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PT REQUESTED A REVISION OF HIS PUMP POCKET TO HIS LEFT ABDOMEN. THE PT STATED THAT HIS "PAIN INCREASED WITH PUMP LOCATED IN RIGHT LOWER QUADRANT." THE REVISION WAS PERFORMED. THE PROXIMAL CATHETER WAS REVISED DUE TO THE POCKET REVISION AND THE DISTAL CATHETER WAS REVISED SECONDARY TO A CHANGE IN PUMP MEDICATION. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVICAINE, FENTANYL AND CLONIDINE. THE PT RECOVERED WITHOUT SEQUELA.
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 | 46 YR | Required Intervention | CATHETER: MODEL 8711, LOT# J12371R07| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| EXPLANTED:| CATHETER: MODEL 8711, LOT# J12371R05| IMPLANTED: |