FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA®
MDR report key: 3840029
·
Received May 30, 2014
Report
- Report Number
- 3006630150-2014-01260
- Event Type
- Injury
- Date Received
- May 30, 2014
- Date of Event
- January 9, 2014
- Report Date
- May 7, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN BELIEVED THAT THE PAIN WAS A NORMAL PROCEDURAL PAIN.
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT AFTER THE PERMANENT IMPLANT PROCEDURE, THE PATIENT HAD COMPLICATIONS WITH PAIN, HYPERSENSITIVITY AT THE POCKET SITE AND RIB PAIN WHEN THE STIMULATOR IS TURNED ON. THE PATIENT WAS PRESCRIBED PAIN MEDICATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT AFTER THE PERMANENT IMPLANT PROCEDURE, THE PATIENT HAD COMPLICATIONS WITH PAIN, HYPERSENSITIVITY AT THE POCKET SITE AND RIB PAIN WHEN THE STIMULATOR IS TURNED ON. THE PATIENT WAS PRESCRIBED PAIN MEDICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319094 | PRECISION SPECTRA® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |