FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2113744
·
Received June 2, 2011
Report
- Report Number
- 3004209178-2011-03911
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 4, 2011
- 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
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A CHANGE IN THERAPY EFFECT; THE PT HAD INCREASED BASELINE PAIN. AT THE LAST PUMP REFILL, THE PT HAD A LARGE VOLUME DISCREPANCY; THE ACTUAL VOLUMES WERE UNK. THE CATHETER WAS REVISED ON (B)(6) 2011. 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 | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N250435| CATHETER: MODEL 8709SC, LOT# N258203012| PROGRAMMER: MODEL 8835, LOT# NPG017967N |