SPECTRA WAVEWRITER?
Report
- Report Number
- 3006630150-2025-07806
- Event Type
- Injury
- Date Received
- September 19, 2025
- Date of Event
- August 21, 2025
- Report Date
- December 2, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC221870, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 5082947, UDI:(B)(4).
CORRECTION TO THE FOLLOW-UP 1 MDR IN BLOCK(S) B5 AND H6. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 5082947. UDI: (B)(4).
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6) BATCH: 5082947 UDI: (B)(4).
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE PHYSICIAN REPLACED THE IMPLANTABLE PULSE GENERATOR (IPG). THE CURRENT LOCATION OF THE EXPLANTED IPG REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION INDICATED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE AS PART OF AN ELECTIVE REPLACEMENT FOR A SYSTEM UPGRADE. THE LOCATION OF THE DEVICE REMAINS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED DESPITE GOOD FAITH EFFORTS.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE PHYSICIAN REPLACED THE IMPLANTABLE PULSE GENERATOR (IPG). THE CURRENT LOCATION OF THE EXPLANTED IPG REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION REVEALED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE AS PART OF AN ELECTIVE UPGRADE OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. HOWEVER, THE SPECIFIC REASON FOR THE LEAD EXPLANT REMAINS UNKNOWN, AND THE CURRENT LOCATION OF THE DEVICES ARE UNKNOWN. NO FURTHER ADVERSE EFFECTS WERE REPORTED, AND DESPITE GOOD FAITH EFFORTS, NO ADDITIONAL INFORMATION WAS AVAILABLE.
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE PHYSICIAN REPLACED THE IMPLANTABLE PULSE GENERATOR (IPG). THE CURRENT LOCATION OF THE EXPLANTED IPG REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1955927 | SPECTRA WAVEWRITER? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 336922 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Female | Required Intervention |