PRECISION®
Report
- Report Number
- 3006630150-2013-00437
- Event Type
- Injury
- Date Received
- March 13, 2013
- Date of Event
- January 14, 2013
- Report Date
- January 14, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-30, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD; 30CM MODEL #: SC-2218-50, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD; 50CM MODEL #: SC-3138-25 SERIAL/LOT #: (B)(4)/397049, DESCRIPTION: SCS PHIII EXT 25CM.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S EXTREME TENDERNESS IN THE BACK HAD RESOLVED AND THE BURNING LEAD SITE PAIN WAS STILL PRESENT. THE PHYSICIAN BELIEVES THE BURNING LEAD SITE PAIN MAY BE DEVICE RELATED SINCE THE PATIENT TESTED POSITIVE FOR SENSITIVITY TO DEVICE COMPONENTS. THE PATIENT WAS ALSO EXPERIENCING PAIN AT THE JOINT AND IPG SITE AND WAS HAVING CHARGING DIFFICULTIES. THE PHYSICIAN DOES NOT BELIEVE THE JOINT PAIN WAS DEVICE RELATED. DATABASE ANALYSIS REVEALED NO ANOMALIES. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
(B)(4). DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE POSSIBILITY THAT ELECTRICAL LEAKAGE COULD CAUSE PAIN IN THE PATIENT¿S POCKET SITE WAS INVESTIGATED. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE AS A RESULT OF FAULTY INSULATION. STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. THE COMPLAINT OF CHARGING DIFFICULTY WAS NOT VERIFIED. THE IPG WAS SUCCESSFULLY CHARGED TO FULL CAPACITY IN ONE CYCLE. PATIENT DATA INDICATED CHARGING DIFFICULTY SIMILAR TO THE CHARACTERISTICS OF TILTED IPG ORIENTATION OR DEEP POCKET. THE IPG PASSED ALL THE REQUIRED TESTS AND REVEALED NO ANOMALIES. SC-3138-25 SN: (B)(4). THE LEAD EXTENSIONS WERE CUT, AND ONLY PROXIMAL ENDS WERE RETURNED. THE DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE.
A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EXTREME TENDERNESS IN THE BACK. PATIENT'S SYMPTOMS INCLUDE WHEEZING AND RASH. THE PHYSICIAN PRESCRIBED STEROID MEDICATIONS. THE PATIENT'S RASH HAS SUBSIDED BUT THE BURNING FEELING OVER THE LEAD SITE IS STILL PRESENT.
A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EXTREME TENDERNESS IN THE BACK. PATIENT¿S SYMPTOMS INCLUDE WHEEZING AND RASH. THE PHYSICIAN PRESCRIBED STEROID MEDICATIONS. THE PATIENT¿S RASH HAS SUBSIDED BUT THE BURNING FEELING OVER THE LEAD SITE IS STILL PRESENT.
A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EXTREME TENDERNESS IN THE BACK. PATIENT'S SYMPTOMS INCLUDE WHEEZING AND RASH. THE PHYSICIAN PRESCRIBED STEROID MEDICATIONS. THE PATIENT'S RASH HAS SUBSIDED BUT THE BURNING FEELING OVER THE LEAD SITE IS STILL PRESENT.
A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EXTREME TENDERNESS IN THE BACK. PATIENT¿S SYMPTOMS INCLUDE WHEEZING AND RASH. THE PHYSICIAN PRESCRIBED STEROID MEDICATIONS. THE PATIENT¿S RASH HAS SUBSIDED BUT THE BURNING FEELING OVER THE LEAD SITE IS STILL PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105417 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| R |