WAVEWRITER ALPHA?
Report
- Report Number
- 3006630150-2023-03509
- Event Type
- Injury
- Date Received
- June 20, 2023
- Date of Event
- May 30, 2023
- Report Date
- July 28, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(6). BATCH: 7073720.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336700. MODEL: SC-8336-70. SERIAL: (B)(6). BATCH: 7073720. SC-1232; (B)(6). THE IPG WAS RETURNED, ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. A LABELING REVIEW WAS PERFORMED ON THE IMPLANTABLE PULSE GENERATOR, IPG, INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. IT STATES SYSTEM FAILURE, WHICH CAN OCCUR AT ANY TIME DUE TO RANDOM FAILURES OF THE COMPONENTS OR THE BATTERY. THESE EVENTS, WHICH MAY INCLUDE DEVICE FAILURE CAN RESULT IN INEFFECTIVE PAIN CONTROL. POSSIBLE SURGICAL PROCEDURAL RISKS ARE TEMPORARY PAIN AT THE IMPLANT SITE, AND PARALYSIS ARE KNOWN RISKS OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SCS. SC-8336-70; (B)(6). THE LEADS' FOUR PROXIMAL TAILS OF THE PADDLE LEAD WERE CLEANLY CUT. THE PADDLE CONTACTS HAVE TRACES OF DRIED BLOOD ON ITS SURFACE, AND THIS IS EXPECTED ON A LEAD THAT WAS IMPLANTED. NO ANOMALIES WERE IDENTIFIED. A LABELING REVIEW WAS PERFORMED ON THE LEADS INSTRUCTIONS FOR USE, IFU. THERE WAS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELED INDICATIONS. IT STATES SYSTEM FAILURE, WHICH CAN OCCUR AT ANY TIME DUE TO RANDOM FAILURE(S) OF THE COMPONENTS OR THE BATTERY, WHICH MAY INCLUDE DEVICE FAILURE, LEAD BREAKAGE, HARDWARE MALFUNCTIONS, LOOSE CONNECTIONS, ELECTRICAL SHORTS OR OPEN CIRCUITS AND LEAD INSULATION BREACHES, CAN RESULT IN INEFFECTIVE PAIN CONTROL. POSSIBLE SURGICAL PROCEDURAL RISKS ARE TEMPORARY PAIN AT THE IMPLANT SITE, AND PARALYSIS. UNDESIRABLE STIMULATION MAY OCCUR OVER TIME DUE TO CELLULAR CHANGES IN TISSUE AROUND THE ELECTRODES, CHANGES IN ELECTRODE POSITION, LOOSE ELECTRICAL CONNECTIONS AND/OR LEAD FAILURE ARE KNOWN RISKS OF IMPLANTING A SYSTEM TO DELIVER SPINAL CORD STIMULATION. BASED ON ALL AVAILABLE INFORMATION, ENGINEERS ARE ABLE TO CONFIRM THE ROOT CAUSE OF THE EVENT. THE DEVICES WERE RETURNED AND ANALYZED, AS SUCH PHYSICAL ANALYSIS WAS CONDUCTED, RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT. THEREFORE, THIS INVESTIGATION IS ABLE TO DETERMINE A PROBABLE ROOT CAUSE FOR THE COMPLAINT AND THE CONCLUSION IS KNOWN INHERENT RISK OF DEVICE.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS; UPN: M365SC8336700; MODEL: SC-8336-70; SERIAL: (B)(6); BATCH: 7073720.
IT WAS REPORTED THAT FOLLOWING THE SPINAL CORD STIMULATOR (SCS) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO MOVE HIS LEGS, EXPERIENCED STIMULATION IN THE ABDOMEN, AND THAT IMPEDANCES WERE NOTED ON THE LEAD. THE PHYSICIAN STATED THAT IT WAS SUSPECTED THAT THE PATIENT SYMPTOMS WERE WORSENING AND THAT HE COULD HAVE SUFFERED A SPINAL CORD INJURY, AND THAT HE THOUGHT IT WAS DUE TO A DEVICE MALFUNCTION AFTER THE INITIAL PROGRAMMING OF THE DEVICE. THE IMPLANTABLE PULSE GENERATOR (IPG) AND PADDLE LEAD WERE BOTH EXPLANTED, RETAINED BY THE FACILITY AND SENT TO PATHOLOGY. ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER ACTIVATION OF THE STIMULATION THE PATIENT DEVELOPED PROGRESSIVELY WORSENING SENSORY AND MOTOR LOSS FROM THE MID TORSO DISTALLY. HE HAD COMPLETE NEUROLOGICAL LOSS ACUTELY. AN MRI WAS RECOMMENDED, HOWEVER DUE TO THE IPG NOT BEING FULLY CHARGED THE DEVICE COULD NOT BE PLACED INTO MRI MODE, CHARGING WAS ATTEMPTED BUT DUE TO THE DELAY A COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS REQUESTED, AND IT SHOWED NO SIGNIFICANT EPIDURAL HEMATOMA. THE DEVICES WERE EXPLANTED AND THE PATIENT WAS GIVEN INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS THEN TRANSPORTED TO THE INTENSIVE CARE UNIT (ICU).
IT WAS REPORTED THAT FOLLOWING THE SPINAL CORD STIMULATOR (SCS) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO MOVE HIS LEGS, EXPERIENCED STIMULATION IN THE ABDOMEN, AND THAT IMPEDANCES WERE NOTED ON THE LEAD. THE PHYSICIAN STATED THAT IT WAS SUSPECTED THAT THE PATIENT SYMPTOMS WERE WORSENING AND THAT HE COULD HAVE SUFFERED A SPINAL CORD INJURY, AND THAT HE THOUGHT IT WAS DUE TO A DEVICE MALFUNCTION AFTER THE INITIAL PROGRAMMING OF THE DEVICE. THE IMPLANTABLE PULSE GENERATOR (IPG) AND PADDLE LEAD WERE BOTH EXPLANTED, RETAINED BY THE FACILITY AND SENT TO PATHOLOGY. ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER ACTIVATION OF THE STIMULATION THE PATIENT DEVELOPED PROGRESSIVELY WORSENING SENSORY AND MOTOR LOSS FROM THE MID TORSO DISTALLY. HE HAD COMPLETE NEUROLOGICAL LOSS ACUTELY. AN MRI WAS RECOMMENDED, HOWEVER DUE TO THE IPG NOT BEING FULLY CHARGED THE DEVICE COULD NOT BE PLACED INTO MRI MODE, CHARGING WAS ATTEMPTED BUT DUE TO THE DELAY A COMPUTERIZED TOMOGRAPHY SCAN (CT SCAN) WAS REQUESTED, AND IT SHOWED NO SIGNIFICANT EPIDURAL HEMATOMA. THE DEVICES WERE EXPLANTED AND THE PATIENT WAS GIVEN INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS THEN TRANSPORTED TO THE INTENSIVE CARE UNIT (ICU).
IT WAS REPORTED THAT FOLLOWING THE SPINAL CORD STIMULATOR (SCS) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO MOVE HIS LEGS, EXPERIENCED STIMULATION IN THE ABDOMEN, AND THAT IMPEDANCES WERE NOTED ON THE LEAD. THE PHYSICIAN STATED THAT IT WAS SUSPECTED THAT THE PATIENT SYMPTOMS WERE WORSENING AND THAT HE COULD HAVE SUFFERED A SPINAL CORD INJURY, AND THAT HE THOUGHT IT WAS DUE TO A DEVICE MALFUNCTION AFTER THE INITIAL PROGRAMMING OF THE DEVICE. THE IMPLANTABLE PULSE GENERATOR (IPG) AND PADDLE LEAD WERE BOTH EXPLANTED, RETAINED BY THE FACILITY AND SENT TO PATHOLOGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545572 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 561005 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Required Intervention |