FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2210322
·
Received August 9, 2011
Report
- Report Number
- 3007566237-2011-06174
- Event Type
- Injury
- Date Received
- August 9, 2011
- Date of Event
- June 2, 2011
- Report Date
- July 19, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1570-2014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S PUMP WAS REPLACED ON (B)(6) 2011. THE REASON FOR THE REMOVAL WAS A DISCREPANCY IN THE RESERVOIR VOLUME. NO PATIENT INJURY WAS REPORTED. THE DRUGS USED IN THE PUMP AT THE TIME OF THE EVENT WERE MORPHINE, BACLOFEN, AND BUPIVICAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Required Intervention | CATHETER: MODEL 8731, LOT # N002601904.| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT # N002601904| IMPLANTED:| EXPLANTED: |