FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2895936
·
Received January 4, 2013
Report
- Report Number
- 3004209178-2013-00135
- Event Type
- Injury
- Date Received
- January 4, 2013
- Report Date
- December 6, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS OF THE PUMP FOUND IT WAS DAMAGED BY CONTRAINDICATED DRUG.
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP GAVE A CRITICAL ALARM "SINCE LAST WEEK" DUE TO MOTOR STALL AND NO TELEMETRY WAS POSSIBLE. THE PUMP WAS REPLACED. PATIENT OUTCOME WAS STATED AS POSITIVE FOLLOWING THE NEW IMPLANT. DRUG DELIVERED VIA THE DEVICE WAS DIAMORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5282 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR | Required Intervention |