PROTEGE IPG, 16-CHANNEL RECHARGEABLE
Report
- Report Number
- 1627487-2022-05192
- Event Type
- Injury
- Date Received
- September 20, 2022
- Date of Event
- August 26, 2022
- Report Date
- March 21, 2023
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT IS ESTIMATED.
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.
E1 INITIAL REPORTER. THE ALLEGATION IS AGAINST 1 OF 3 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3189, UDI: (B)(4), BATCH: 4340795. COMMON DEVICE NAME: SCS OCTRODE LEAD, MODEL: 3189, UDI: (B)(4), BATCH: 4210954. 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.
IT WAS REPORTED THE PATIENT'S IPG IS INOPERABLE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.
MANUFACTURER REPORT NUMBER 1627487-2023-01089. ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT'S IPG AND LEAD WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2699066 | PROTEGE IPG, 16-CHANNEL RECHARGEABLE | SCS IPG | LGW | ABBOTT MEDICAL | 3789 | 4763286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other | SCS ANCHORS X 2.| SCS LEADS X 3. |