FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2900524
·
Received January 7, 2013
Report
- Report Number
- 3004209178-2013-00279
- Event Type
- Injury
- Date Received
- January 7, 2013
- Report Date
- December 12, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS OF THE PUMP REVEALED NO ANOMALIES IN THE PUMP LOGS, AND THE PUMP PASSED ALL NON-DESTRUCTIVE LAB TESTING. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE MOTOR STALLS OCCURRED OVER MULTIPLE DAYS. A RECOVERY WAS NOTED WITHIN TWO HOURS. A DYE STUDY WAS NEGATIVE. THE PATIENT EXPERIENCED UNDERDOSE DESCRIBED AS WITHDRAWAL SYMPTOMS. THE PUMP WAS EXPLANTED. THE DRUG IN THE PUMP WAS INFUMORPH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7317 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00056 YR | Required Intervention |