SCS CONVENTIONAL IPG
Report
- Report Number
- 1627487-2023-06012
- Event Type
- Death
- Date Received
- December 20, 2023
- Date of Event
- April 12, 2021
- Report Date
- November 7, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- LGW
- UDI-DI
- 05415067031419
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED."
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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED. CORRECTION: SECTION H1 - TYPE OF REPORTABLE EVENT SHOULD HAVE HAD DEATH CHECKED OFF IN ADDITIONAL REPORT 1. THIS CORRECTION IS REFLECTED IN THIS ADDITIONAL REPORT 2.
DATE OF EVENT IS ESTIMATED. A PATIENT EXPERIENCING MIGRATION AT THE IPG SITE WAS REPORTED TO ABBOTT. 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 EVENT COULD NOT BE CONCLUSIVELY DETERMINED.
CORRECTION: SECTION H6 - MEDICAL DEVICE PROBLEM CODE SHOULD HAVE BEEN "2993 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM" INSTEAD OF "4003 - MIGRATION" FOR THIS EVENT. THIS CORRECTION IS REFLECTED IN THIS ADDITIONAL REPORT 3.
ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT UNDERWENT A SYSTEM REPLACEMENT ON (B)(6) 2021 FROM A COMPETITOR SYSTEM TO AN ABBOTT SYSTEM DUE TO THE COMPETITOR (NUVECTRA) IPG MIGRATING. THE PATIENT WAS INFORMED BY THE PHYSICIAN THAT SINCE THE COMPETITOR COMPANY WENT OUT OF BUSINESS, THE PATIENT COULD NOT RECEIVE NEW PROGRAMS OR SUPPORT WITH THE NUVECTRA IPG AND THEREFORE WAS THE REASON THE SYSTEM WAS CHANGED TO AN ABBOTT SYSTEM. PER THE PATIENT¿S SPOUSE, THE PATIENT WAS IMPLANTED WITH THE ABBOTT SYSTEM AND BECAME PARAPLEGIC AFTER THE IMPLANT. THE DOCTOR INFORMED THE SPOUSE THIS OCCURRED DUE TO BRUISING OF THE SPINAL CORD. THE PATIENT DID REGAIN SOME PAIN SENSATION, TEMPERATURE, AND VERY SLIGHT MOVEMENT. THE PATIENT SOON DEVELOPED UTI'S RELATED TO THE FOLEY CATHETER, BECAME SEPTIC AND PASSED AWAY ON (B)(6) 2023. PER THE ABBOTT REP, THE PATIENT WAS STABLE IMMEDIATELY POST-IMPLANT AND WAS NOT REQUESTED FOR FURTHER SERVICES. THE ABBOTT REP WAS UNAWARE OF THE PARALYSIS AND DEATH.
RECEIVED FROM MW5148434. PARALYSIS DUE TO SPINAL CORD STIMULATOR OPERATION (B)(6) 2021. GASTRIC BYPASS COMPLICATIONS, LEG INJURIES / CONNECTIONS, CEREBRAL PALSY. MY WIFE HAD SPINAL CORD STIMULATOR OPERATION FOR PAIN CONTROL / LEG INJURIES. (B)(6). THINK (B)(6) 2019. (B)(6) WENT BANKRUPT. DR (B)(6) SAID WE JUST THOUGHT THEY WOULD BE BOUGHT OUT. BATTERY PACK MIGRATED, THERE WAS NO MORE INTEL OR PROGRAMMING UPDATES. AFTER FIRST SAYING THERE WAS AN ABBOTT INTERFACE FOR EXISTING LEAD, OR (B)(4) REPLACED WHOLE SYSTEM. MY WIFE WAS PARALYZED FROM WAIST DOWN IN WHAT WAS SUPPOSED TO OUTPATIENT DAY SURGERY AT (B)(6) HOSPITAL. SHE HAD A LOT OF BRUISING AS THOUGHT SHE HAD BEEN DROPPED, WAS FIRST TOLD SPINAL CORD BRUISE WOULD HEAL UP, UP TO TAKE TWO YEARS, NEVER HEALED UP. SHE HAD FOLEY CATHETERS AND SUPRAPUBIC (AT (B)(6) WHERE SHE TAKEN AGAINST HER WISHES). SHE HAD REPEATED UTIS AND THIS IS BASICALLY WHAT KILLED HER, SEPSIS. THEY NEED TO STOP DOING THESE SPINAL CORD STIMULATOR OPERATIONS. LEFT PARALYZED AND NOW DEAD. PARALYZED FOR TWO YEARS. DON'T KNOW IF IT WAS DEVICE OR SURGEON. SHE WAS (B)(6), DOB: (B)(6) 1965, (B)(6). I AM (B)(6). REF REPORTS: MW5148435 AND MW5148436.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306256 | SCS CONVENTIONAL IPG | SCS LEAD | LGW | ABBOTT MEDICAL | 3228 | 7797043 | 05415067031419 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other| D | SCS IPG |