FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1910723
·
Received November 22, 2010
Report
- Report Number
- 3004209178-2010-09853
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 15, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT HAD ALWAYS EXPERIENCED SOME PAIN. IN (B)(6) 2010, THE ACTUAL RESIDUAL PUMP VOLUME (7ML) WAS GREATER THAN THE EXPECTED VOLUME (3.5 ML); NOTHING WAS DONE BECAUSE IT WAS WITHIN SPEC. THERE WERE NO PUMP ALARMS. A THERAPEUTIC BOLUS WAS GIVEN AND THE PT RESPONDED. THE MEDICATION BEING DELIVERED VIA THE PT'S DEVICE SYSTEM WAS UNK; HOWEVER, THE PT WAS ON MULTIPLE DRUGS AT A HIGH DOSE/CONCENTRATION. THE PT HAD A CATHETER REVISION ON (B)(6) 2010 TO PLACE THE TIP OF THE CATHETER HIGHER IN THE SPINE. 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 | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8578, LOT #: N239524001| CATHETER: MODEL 8709, LOT #: J12205R30| IMPLANTED:| EXPLANTED: |