FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2113705
·
Received June 2, 2011
Report
- Report Number
- 3007566237-2011-03934
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- March 17, 2011
- Report Date
- May 5, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED UNSPECIFIED WITHDRAWAL SYMPTOMS. THE PT'S PUMP MOTOR STALLED. THE PT DID NOT HAVE AN MRI THAT MAY HAVE CAUSE THE STALL. THE PUMP HAD AND ERI (ELECTIVE REPLACEMENT INDICATOR) OF (B)(6). THE PUMP WAS REPLACED. THE MEDICATIONS IN THE PUMP WERE BUPIVACAINE, AND MORPHINE. 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 | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N004981025 |