FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA? PRIME 16
MDR report key: 19973381
·
Received August 13, 2024
Report
- Report Number
- 3006630150-2024-05302
- Event Type
- Injury
- Date Received
- August 13, 2024
- Date of Event
- July 15, 2024
- Report Date
- April 24, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985068
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7141069/7145765.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD A STAPHYLOCOCCUS AUREUS INFECTION AT THE INCISION SITE. SYMPTOM OF DRAINAGE AT THE SITE WAS NOTED. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AND UNDERWENT AN EXPLANT PROCEDURE, ALSO, THE PATIENT WAS PLACED ON INTRAVENOUS (IV) ANTIBIOTICS. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IPG AND LEADS WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606734 | WAVEWRITER ALPHA? PRIME 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1416 | 226852 | 08714729985068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention| H |