PRECISION
Report
- Report Number
- 3006630150-2023-07993
- Event Type
- Injury
- Date Received
- December 21, 2023
- Date of Event
- December 7, 2020
- Report Date
- May 20, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767688
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY SCS-LINEAR LEADS UPN M365SC2218300. MODEL SC-2218-30. SERIAL- (B)(6). BATCH 202724 AND 202735. SC-1110-02, SERIAL (B)(6). ANALYSIS OF THE RETURNED IPG REVEALED NORMAL DEVICE CHARACTERISTICS AND WAS ABLE TO BE CHARGED IN ONE FOUR-HOUR CHARGE CYCLE WITHOUT ANY ANOMALIES AND PASSED ALL TESTING. HOWEVER, THE DATA LOG REVEALED THE THERMISTOR HAD BEEN TRIGGERED MULTIPLE TIMES AND THAT THE CHARGER MAY HAVE BEEN MISALIGNED WITH THE IPG. A PRODUCT LABELING REVIEW THAT WAS CONDUCTED DETERMINED THAT THE CHARGER SHOULD BE WELL VENTILATED AND SHOULD NOT BE USED IF THE AMBIENT TEMPERATURE EXCEEDS 35 DEGREES CELSIUS. THEREFORE, ENGINEERS CONCLUDED THE PROBABLE CAUSE OF THE EVENT WAS FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE, IFU. SC-2218-30, SERIAL (B)(6). THE LEADS WERE DISPOSED OF AND WERE NOT RETURNED FOR ANALYSIS. THEREFORE, A PHYSICAL ANALYSIS HAS NOT BEEN CONDUCTED IN OUR LABORATORY. THERE WAS NO ALLEGATION AGAINST THE LEADS.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT. PRODUCT FAMILY SCS-LINEAR LEADS: UPN M365SC2218300. MODEL SC-2218-30. SERIAL-LOT (B)(6) AND(B)(6). BATCH 202724 AND 202735.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY SCS-LINEAR LEADS, UPN M365SC2218300, MODEL SC-2218-30, SERIAL-LOT (B)(6), BATCH 202724 AND 202735.
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS AGO, THE PATIENTS SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) STOPPED WORKING. THE PATIENT EXPERIENCED DIFFICULTY CHARGING THE IPG, AND IT WOULD NO LONGER COMMUNICATE WITH THE REMOTE CONTROL. THE IPG BECAME COMPLETELY DEPLETED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN REPLACED THE ENTIRE SYSTEM, WHICH CONSISTED OF ONE IPG AND TWO LEADS. THERE WERE NO COMPLICATIONS, AND THE NEW SYSTEM WORKS FINE. THE LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE MALFUNCTION WAS SUSPECTED TO BE THE IPG ONLY.
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS AGO, THE PATIENTS SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) STOPPED WORKING. THE PATIENT EXPERIENCED DIFFICULTY CHARGING THE IPG, AND IT WOULD NO LONGER COMMUNICATE WITH THE REMOTE CONTROL. THE IPG BECAME COMPLETELY DEPLETED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN REPLACED THE ENTIRE SYSTEM, WHICH CONSISTED OF ONE IPG AND TWO LEADS. THERE WERE NO COMPLICATIONS, AND THE NEW SYSTEM WORKS FINE. THE LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE MALFUNCTION WAS SUSPECTED TO BE THE IPG ONLY.
IT WAS REPORTED THAT APPROXIMATELY THREE YEARS AGO, THE PATIENTS SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) STOPPED WORKING. THE PATIENT EXPERIENCED DIFFICULTY CHARGING THE IPG, AND IT WOULD NO LONGER COMMUNICATE WITH THE REMOTE CONTROL. THE IPG BECAME COMPLETELY DEPLETED. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE PHYSICIAN REPLACED THE ENTIRE SYSTEM, WHICH CONSISTED OF ONE IPG AND TWO LEADS. THERE WERE NO COMPLICATIONS, AND THE NEW SYSTEM WORKS FINE. THE LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED AT THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298472 | PRECISION | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | 195003 | 08714729767688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |