WAVEWRITER ALPHA? PRIME 16
Report
- Report Number
- 3006630150-2024-08378
- Event Type
- Injury
- Date Received
- December 4, 2024
- Date of Event
- November 8, 2024
- Report Date
- April 30, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985068
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.
CORRECTION FOR FIELD H11: ADDITIONAL MFR NARRATIVE: ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7150470. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7150269. UDI: (B)(4).
IT WAS REPORTED THAT THERE WAS A SMALL SUTURE POKING THROUGH THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) INCISION CAUSING DISCOMFORT. IT WAS ALSO STATED THAT THERE WAS A SMALL SEROMA NOTED UNDER THE SKIN. THE PATIENT UNDERWENT AN IPG POCKET INCISION CLEANING AND WOUND DRESSING. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
IT WAS REPORTED THAT THERE WAS A SMALL SUTURE POKING THROUGH THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) INCISION CAUSING DISCOMFORT. IT WAS ALSO STATED THAT THERE WAS A SMALL SEROMA NOTED UNDER THE SKIN. THE PATIENT UNDERWENT AN IPG POCKET INCISION CLEANING AND WOUND DRESSING. THE PATIENT WAS ALSO EXPERIENCING CONSTANT PAIN AROUND THE IPG SITE AND SHOCKING SENSATION WHILE THE IPG WAS TURNED OFF. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE EXPLANTED AND THE EXPLANTED DEVICES WILL NOT BE RETURNED.
IT WAS REPORTED THAT THERE WAS A SMALL SUTURE POKING THROUGH THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) INCISION CAUSING DISCOMFORT. IT WAS ALSO STATED THAT THERE WAS A SMALL SEROMA NOTED UNDER THE SKIN. THE PATIENT UNDERWENT AN IPG POCKET INCISION CLEANING AND WOUND DRESSING. THE PATIENT WAS ALSO EXPERIENCING CONSTANT PAIN AROUND THE IPG SITE AND SHOCKING SENSATION WHILE THE IPG WAS TURNED OFF. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE EXPLANTED AND THE EXPLANTED DEVICES WILL NOT BE RETURNED.
IT WAS REPORTED THAT THERE WAS A SMALL SUTURE POKING THROUGH THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) INCISION CAUSING DISCOMFORT. IT WAS ALSO STATED THAT THERE WAS A SMALL SEROMA NOTED UNDER THE SKIN. THE PATIENT UNDERWENT AN IPG POCKET INCISION CLEANING AND WOUND DRESSING. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ALSO EXPERIENCING CONSTANT PAIN AROUND THE IPG SITE AND SHOCKING SENSATION WHILE THE IPG WAS TURNED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2113726 | WAVEWRITER ALPHA? PRIME 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1416 | 228215 | 08714729985068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention |