PRECISION®
Report
- Report Number
- 3006630150-2011-01119
- Event Type
- Injury
- Date Received
- July 27, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE RETURNED IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE, AND PHOTOGRAPHIC INSPECTION TESTS. THE FAILURE ANALYSIS COULD NOT DETERMINE THE PROGRAMMED STIMULATION CAUSED THE REPORTED PRESSURE/PAIN AT THE IPG SITE. AS THE COMPLAINT ITSELF IS SUBJECTIVE, THE FAILURE ANALYSIS WAS TO VERIFY WHETHER THE DEVICE IS GENERATING UNREGULATED STIMULATIONS. TWO CONCURRENT STIMULATIONS, "FONT LEG" AND "BACK LEG" WERE RUNNING CONCURRENTLY WHEN THE LATEST SETTING WAS ACTIVATED. WHILE THE OUTPUTS WERE MONITORED ON A SCOPE, THE AMPLITUDE AND PULSE WIDTH OF THE SETTING WERE MEASURED AND VERIFIED TO BE CORRECT ON ALL ELECTRODES. THE SEEPROM DATA WAS EXAMINED, AND NO ANOMALIES WERE FOUND. THE DC/CURRENT LEAKAGE TESTS VERIFIED THAT THE DEVICE DOES NOT ALLURE THE SURROUNDING MASS. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S IPG WAS REPLACED AND RELOCATED DUE TO PAIN AT THE POCKET SITE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG FOUND THEM TO BE SATISFACTORY.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN, SENSITIVITY AND BURNING AT THE POCKET SITE. THE PHYSICIAN DETERMINED THAT THE POCKET WAS NORMAL. THE PATIENT WAS GIVEN NEW PROGRAMS, BUT THE ISSUE WAS NOT RESOLVED. THE IPG DATABASE ANALYSIS CONFIRMED THE DEVICE WAS WORKING PROPERLY. THE PHYSICIAN PRESCRIBED LIDOCAINE PATCHES FOR THE PATIENT TO APPLY TO THE POCKET SITE, BUT THE PATIENT DID NOT NOTICE A REDUCTION IN PAIN. THE PHYSICIAN HAS RECOMMENDED A POCKET REVISION.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN, SENSITIVITY AND BURNING AT THE POCKET SITE. THE PHYSICIAN DETERMINED THAT THE POCKET WAS NORMAL. THE PATIENT WAS GIVEN NEW PROGRAMS, BUT THE ISSUE WAS NOT RESOLVED. THE IPG DATABASE ANALYSIS CONFIRMED THE DEVICE WAS WORKING PROPERLY. THE PHYSICIAN PRESCRIBED LIDOCAINE PATCHES FOR THE PATIENT TO APPLY TO THE POCKET SITE, BUT THE PATIENT DID NOT NOTICE A REDUCTION IN PAIN. THE PHYSICIAN HAS RECOMMENDED A POCKET REVISION.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN, SENSITIVITY AND BURNING AT THE POCKET SITE. THE PHYSICIAN DETERMINED THAT THE POCKET WAS NORMAL. THE PATIENT WAS GIVEN NEW PROGRAMS, BUT THE ISSUE WAS NOT RESOLVED. THE IPG DATABASE ANALYSIS CONFIRMED THE DEVICE WAS WORKING PROPERLY. THE PHYSICIAN PRESCRIBED LIDOCAINE PATCHES FOR THE PATIENT TO APPLY TO THE POCKET SITE, BUT THE PATIENT DID NOT NOTICE A REDUCTION IN PAIN. THE PHYSICIAN HAS RECOMMENDED A POCKET REVISION.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN, SENSITIVITY AND BURNING AT THE POCKET SITE. THE PHYSICIAN DETERMINED THAT THE POCKET WAS NORMAL. THE PATIENT WAS GIVEN NEW PROGRAMS, BUT THE ISSUE WAS NOT RESOLVED. THE IPG DATABASE ANALYSIS CONFIRMED THE DEVICE WAS WORKING PROPERLY. THE PHYSICIAN PRESCRIBED LIDOCAINE PATCHES FOR THE PATIENT TO APPLY TO THE POCKET SITE, BUT THE PATIENT DID NOT NOTICE A REDUCTION IN PAIN. THE PHYSICIAN HAS RECOMMENDED A POCKET REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |