FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3092338
·
Received May 3, 2013
Report
- Report Number
- 3007566237-2013-01521
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- April 13, 2013
- Report Date
- April 13, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. PRODUCT ID: 85 96SC, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN OVERDOSE OCCURRED FOLLOWING A NEW PUMP IMPLANT AND CATHETER REVISION. THE HEALTH CARE PROVIDER (HCP) ASPIRATED 0.2 MILLILITERS (ML) FROM THE CATHETER AND THEN PERFORMED A DYE STUDY. AFTER THE HCP INJECTED THE DYE, THE PATIENT'S RESPIRATORY RATE DECREASED AND THE PATIENT WAS ADMINISTERED NARCAN. THIS DEVICE SYSTEM DELIVERED MORPHINE. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING "FINE" AND NOTED TO RECEIVE THERAPEUTIC EFFECT FROM THE PUMP FOLLOWING THE THREE WEEK FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195125 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR | Required Intervention |