FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1926047
·
Received November 10, 2010
Report
- Report Number
- 3004209178-2010-09231
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Report Date
- October 22, 2010
- 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
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT NEVER HAD THERAPEUTIC EFFECT SINCE THE IMPLANT THREE YEARS AGO AND WAS IN "WORSE PAIN" NOW THAN PRIOR TO IMPLANT. THE PT HAD CHRONIC PAIN IN L4 AND L5 THAT WAS NOT RELIEVED WITH PUMP THERAPY. THE PT'S PAIN LEVEL WAS A 7. THE PUMP WAS DUE TO BE REFILLED NEXT JANUARY. THE PT EXPERIENCED DIZZINESS WHEN A BOLUS WAS DELIVERED VIA THE PROGRAMMER. IT ALSO WAS REPORTED THAT THE PT HAD DIFFICULTY POWERING ON THE PROGRAMMER DESPITE RECENTLY CHANGING THE BATTERIES. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE DILAUDID AND BUPIVICAINE. 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 | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT # N261006010| EXPLANTED:| PROGRAMMER: MODEL 8835, LOT # NPG017647N| IMPLANTED: |