FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2841252
·
Received November 21, 2012
Report
- Report Number
- 3004209178-2012-10597
- Event Type
- Injury
- Date Received
- November 21, 2012
- Report Date
- October 24, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PROGRAMMER MODEL: 8835, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: UNK; CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: UNK; CATHETER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: UNK. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT HAD EXPERIENCED "SIGNIFICANT WARMTH" AT PUMP POCKET SITE DURING A CERVICAL MRI, THREE MINUTES WITHIN BEING IN THE SCANNER. PATIENT STOPPED THE STUDY BECAUSE OF THE "HEATING SENSATION". PATIENT WAS ON THEIR WAY TO MANAGING PHYSICIAN TO HAVE THE PUMP CHECKED AFTER MRI. DRUGS DELIVERED VIA THE DEVICE WERE FENTANYL AND ZICONOTIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |