FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 20218953
·
Received September 14, 2024
Report
- Report Number
- 3006630150-2024-06125
- Event Type
- Injury
- Date Received
- September 14, 2024
- Date of Event
- August 20, 2024
- Report Date
- September 13, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500 MODEL: SC-2317-50 SERIAL: (B)(6). BATCH: 7071632.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT KEEPING A CHARGE. IT WAS ALSO NOTED THAT THE INFINION LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT IPG AND LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION SUSPECTED. THE EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED PER FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1209336 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 372633 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Required Intervention |