RENEW RECEIVER KIT, 16-CHANNEL
Report
- Report Number
- 1627487-2021-17966
- Event Type
- Injury
- Date Received
- October 27, 2021
- Date of Event
- April 7, 2021
- Report Date
- December 14, 2021
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
CORRECTION: B5.
THE REPORTED EVENT FOR INEFFECTIVE STIMULATION/NON-FUNCTIONAL SCS WAS CONFIRMED. AS RECEIVED, THE RF RECEIVER SUCCESSFULLY COMMUNICATED WITH A LAB STANDARD RF TRANSMITTER. THE IPG WAS FUNCTIONALLY TESTED AND FAILED DUE TO DEGRADED OUTPUTS. THIS IS CONSISTENT WITH THE FAILURE OF THE INTERNAL HYBRID CIRCUITS.
CORRECTION G3 : DATE RECEIVED BY MANUFACTURER.
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17967, 1627487-2021-18143.
DATE OF EVENT IS ESTIMATED. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT AND DEVICE INFORMATION. THE UNIQUE DEVICE IDENTIFIER (UDI #) IS UNKNOWN BECAUSE THE LOT AND PART NUMBER WERE NOT PROVIDED.
RELATED MANUFACTURER REFERENCE NUMBER: (B)(4). IT WAS REPORTED THE PATIENT'S SYSTEM WAS EXPLANTED. REASON FOR EXPLANT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1603381 | RENEW RECEIVER KIT, 16-CHANNEL | SCS IPG | LGW | ABBOTT MEDICAL | 3416 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Other | NMD0002 LEAD| NMD0002 LEAD X 2| NMD0002 LEAD |