FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3193355
·
Received June 27, 2013
Report
- Report Number
- 3004209178-2013-10975
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Report Date
- May 30, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL #(B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
THE PATIENT REPORTED THAT, SINCE THEY HAD THEIR PAIN PUMP, IT CUT THEIR CELL PHONE COMPLETELY OFF IN MID CONVERSATION. THEY CONFIRMED THAT THE PAIN PUMP MADE THE PHONE HANG UP, AND THEY HAD READ THAT IN THE DRUG DELIVERY THERAPY FOR CHRONIC PAIN MANUAL. THE PATIENT NOTED THEY CALLED THEIR HEALTHCARE PROVIDER SIXTEEN TIMES BECAUSE THEIR PHONE KEPT DROPPING ALL THE CALLS. NO SYMPTOMS WERE REPORTED. THE SYSTEM WAS INFUSING SALINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292775 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00043 YR |