FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2070124
·
Received April 21, 2011
Report
- Report Number
- 3004209178-2011-02996
- Event Type
- Injury
- Date Received
- April 21, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 7, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- 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
IT WAS REPORTED THAT THE PT EXPERIENCED AN OVERDOSE AFTER A PUMP REPLACEMENT. THE PT WAS ADMITTED TO THE HOSPITAL FOR 2 DAYS AND WAS DISCHARGED ON (B)(6) 2011 AFTER BEING STABILIZED. THE PT'S DOSAGE WAS DECREASED BY 30%, BUT THE PT WAS STILL VERY SLEEP/GROGGY. THE PT'S WIFE WAS CONCERNED ABOUT HER HUSBAND'S CONDITION BECAUSE OF THE WEEKEND AND DUE TO THE FACT THAT THEY LIVED ONE HOUR AWAY FROM THE HOSPITAL. THEY HAD PLANNED TO FOLLOW-UP WITH THE HCP. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS DILAUDID. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 | 68 YR | Hospitalization | CATHETER: MODEL 8709, LOT# J11558R52| IMPLANTED:| EXPLANTED: |