FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1923219
·
Received November 9, 2010
Report
- Report Number
- 3004209178-2010-09135
- Event Type
- Malfunction
- Date Received
- November 9, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 20, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S PUMP DEVICE HAD A MOTOR STALL. IT WAS STATED THE PT'S HEALTH CARE PROVIDER CONFIRMED THE STALL, AND STATED MULTIPLE STALLS HAD OCCURRED SINCE AN MRI. NO SYMPTOMS WERE REPORTED. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVICAINE AND DILAUDID. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U 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 | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | CATHETER: MODEL 8709, LOT# L74359| IMPLANTED:| EXPLANTED: |