FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2001547
·
Received January 26, 2011
Report
- Report Number
- 3004209178-2011-00633
- Event Type
- Malfunction
- Date Received
- January 26, 2011
- Date of Event
- December 22, 2010
- Report Date
- January 20, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A VOLUME DISCREPANCY WAS REPORTED WITH INCREASED BASELINE PAIN ON (B)(6) 2010. THE ACTUAL RESIDUAL VOLUME WAS MORE THAN THE EXPECTED RESIDUAL VOLUME. IT WAS UNCLEAR WHAT THE EXACT AMOUNTS WERE OR WHAT THE PERCENTAGE OF ACCURACY WAS. IT WAS STATED THAT THE PT HAD A VOLUME DISCREPANCY OF GREATER THAN 25% AT HER PREVIOUS REFILL SESSION TWO MONTHS PRIOR. ON (B)(6) 2010, THE PHYSICIAN WAS UNABLE TO ASPIRATE THROUGH THE CATHETER ACCESS PORT. A CATHETER REVISION/REPLACEMENT WAS PLANNED FOR (B)(6) 2011. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP 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 | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED:| EXPLANTED: |