FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1970148
·
Received January 14, 2011
Report
- Report Number
- 3004209178-2011-00397
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- December 1, 2010
- Report Date
- January 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
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT HAD THEIR CATHETER REVISED ON (B)(6) 2010 BECAUSE WHEN THE PUMP WAS REFILLED, THEY FOUND THAT THE CATHETER "HAD PULLED LOOSE". THE PT COULDN'T TELL IF THE PUMP WAS HELPING WITH THEIR PAIN YET. IT WAS ALSO REPORTED THAT THE PT FELL TWO NIGHTS PRIOR TO THIS REPORT ON THEIR LEFT SIDE. THE PT WENT TO THEIR PHYSICIAN ON (B)(6) 2010 FOR A DOSAGE INCREASE. THE PT WAS NOT SURE IF THE FALL AFFECTED THE PUMP. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L 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 | 75 YR | Required Intervention | EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG016958N| CATHETER: MODEL 8709SC, LOT# N252944003| IMPLANTED: |