FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1822448
·
Received August 26, 2010
Report
- Report Number
- 3004209178-2010-06491
- Event Type
- Injury
- Date Received
- August 26, 2010
- Date of Event
- April 7, 2010
- Report Date
- July 29, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FINAL DEVICE ANALYSIS OF THE RETURNED PUMP AND CATHETER SEGMENTS REVEALED NO ANOMALY FOUND; NORMAL DEVICE FUNCTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS EXPLANTED AND REPLACED ON (B)(6) 2010 FOR NORMAL BATTERY DEPLETION. SUBSEQUENTLY, THE PT EXPERIENCED SPINAL HEADACHE, POSSIBLE CSF LEAK. ON (B)(6) 2010 AN INTERVENTION WAS PERFORMED; ADDED PURSE STRING. THE PT OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2010. THE MEDICATION IN THE PUMP WAS NOTED AFTER THE EVENT OCCURRED AS MORPHINE 8.0 MG/ML WITH A DOSE OF 3.0007 MG/DAY, BUPIVACAINE 40 MG/ML WITH A DOSE OF 15.004 MG/DAY, AND BACLOFEN 800 MCG/ML WITH A DOSE OF 300.07 MCG/DAY AS OF (B)(6) 2010.
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 | 53 YR | Required Intervention | IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8627L18,| CATHETER: MODEL CATHETER, LOT # UNK| CATHETER: MODEL 8709, LOT # N246662006| EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT # NGH017896R| IMPLANTED: |