FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2181234
·
Received July 22, 2011
Report
- Report Number
- 3007566237-2011-05657
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- June 26, 2011
- Report Date
- June 28, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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
IT WAS REPORTED THAT THE PT EXPERIENCED BACLOFEN WITHDRAWAL SYMPTOMS THAT WERE UNCONTROLLED WITH ORAL MEDS. THE PT HAD MUSCLE PAIN/MUSCLE SPASMS IN BACK AND LEGS WHICH HAD INCREASED SINCE IMPLANT. PT ALSO EXPERIENCED HYPOXIA AND HYPOTENSION. PT WAS GIVEN ORAL BACLOFEN, PROLACTIN AND VALIUM. THE PT WAS UNABLE TO TOLERATE THE BACLOFEN WITHDRAWAL SYMPTOMS WITH THE ORAL MEDS, SO WAS HOSPITALIZED (B)(6) EARLIER THAN THE PLANNED CATHETER REVISION. THE CATHETER REVISION WAS SCHEDULED FOR (B)(6) 2011. THE PT OUTCOME WAS REPORTED AS "ONGOING EVENT." A F/U 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 NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | EXPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT # UNK |