FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA 16
MDR report key: 14495774
·
Received May 25, 2022
Report
- Report Number
- 3006630150-2022-02457
- Event Type
- Injury
- Date Received
- May 25, 2022
- Date of Event
- April 1, 2022
- Report Date
- May 25, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985082
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 3173775/7070285.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS HAVING DISCOMFORT AND PAIN AT THE IPG SITE. THE PATIENT WAS ALSO HAVING DIFFICULTY CHARGING THE IPG. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE POCKET SITE WAS RELOCATED FROM THE FLANK TO THE BUTTOCK AND THE IPG WAS REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED IPG WAS DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2114878 | WAVEWRITER ALPHA 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1216 | 509736 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention |