FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2023963
·
Received March 18, 2011
Report
- Report Number
- 3006630150-2011-00374
- Event Type
- Injury
- Date Received
- March 18, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2218-70E (B)(4) DESCRIPTION:ST LINEAR TRIAL LEAD, 70CM WITH PRE-LOADED 0.014 INCHES STYLET (STREAMLINED).
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT DURING A TRIAL IMPLANT PROCEDURE, THE PATIENT'S HEART RATE DROPPED. THE PHYSICIAN ABORTED THE PROCEDURE AND INJECTED THE PATIENT WITH ROVINOL 0.4MG. THE PHYSICIAN WAS UNSURE AS TO WHAT MAY HAVE CAUSED THE DROP IN HEART RATE, HOWEVER STATED THAT IT WAS NOT DEVICE RELATED. THE PATIENT IS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-70E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |