FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1972396
·
Received January 20, 2011
Report
- Report Number
- 3004209178-2011-00499
- Event Type
- Injury
- Date Received
- January 20, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 11, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS OF AGITATION, COMBATIVENESS, AND TREMORS. THE PATIENT HAD A PROGRAMMING SESSION ON (B)(6) 2011, WITH A DOSAGE INCREASE. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT'S MANAGING PHYSICIAN HAD NOT YET BEEN CONTACTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS FENTANYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, 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 | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Hospitalization | EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N261058003| IMPLANTED: |