FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 14625668
·
Received June 7, 2022
Report
- Report Number
- 3006630150-2022-02733
- Event Type
- Injury
- Date Received
- June 7, 2022
- Date of Event
- May 27, 2021
- Report Date
- June 7, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN : M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7072472/7073173.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE, BURNING SENSATION, INADEQUATE STIMULATION AND OVERSTIMULATION DESPITE REPROGRAMMING ATTEMPTS. IT WAS ALSO NOTED THAT THE IPG PLACEMENT WAS UNCOMFORTABLE FOR THE PATIENT. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1141516 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 376801 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Required Intervention |