FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 10372103
·
Received August 6, 2020
Report
- Report Number
- 3006630150-2020-03275
- Event Type
- Injury
- Date Received
- August 6, 2020
- Date of Event
- July 15, 2020
- Report Date
- August 6, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI: UPN: (B)(4), MODEL: SC-8416-70, SERIAL: (B)(4), BATCH: 7070074.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE DUE TO IPG MIGRATION. THE PATIENT UNDERWENT A POCKET REVISION AND THE PHYSICIAN NOTICED SIGNS OF INFECTION ON BOTH THE IPG AND LEAD SITE. THE PATIENT'S SCS SYSTEM WAS EXPLANTED TO PREVENT THE SPREAD OF INFECTION AND THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PHYSICIAN BELIEVED THAT THE CAUSE OF INFECTION WAS UNKNOWN HOWEVER, IT WAS PROCEDURE RELATED. THE EXPLANTED DEVICES WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838495 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 367457 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |