REACTIV8
Report
- Report Number
- 3013017877-2024-00055
- Event Type
- Injury
- Date Received
- July 18, 2024
- Date of Event
- June 19, 2024
- Report Date
- September 20, 2024
- Manufacturer
- MAINSTAY MEDICAL LIMITED
- Product Code
- QLK
- UDI-DI
- 05391527770015
- PMA / PMN Number
- P190021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MML REF #: (B)(4). B2-OTHER: PAIN/DISCOMFORT.
MML REF #: (B)(4). B2-OTHER: PAIN/DISCOMFORT. PATIENT DEMOGRAPHIC INFORMATION WAS ADDED. NO PART WAS RETURNED FOR EVALUATION; NO DEVICE EVALUATION CAN BE PERFORMED. THE DEVICE MANUFACTURING RECORD WAS REVIEWED. NO RELEVANT NON-CONFORMANCES WERE FOUND. OTHER DEVICES EXPLANTED: MODEL: 8145. DESCRIPTION: PERCUTANEOUS STIMULATION LEADS. SERIAL NUMBERS: B)(6). UDI #: (B)(4).
IT WAS REPORTED THAT THE PATIENT'S PAIN HAD GOTTEN WORSE SINCE THE DEVICE WAS IMPLANTED. MAINSTAY MEDICAL REPRESENTATIVE CONTACTED THE IMPLANTING PHYSICIAN, WHO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PRESSING ON THE ILIAC CREST, CAUSING RADICULAR-LIKE SYMPTOMS. AN X-RAY, COMPUTED TOMOGRAPHY (CT) SCAN, AND MAGNETIC RESONANCE IMAGING (MRI) CONFIRMED THIS WAS NOT THE CASE. THE REACTIV8 SYSTEM WAS EXPLANTED. ALL PARTS WERE REMOVED AND INTACT. PER THE HOSPITAL'S PROTOCOL, NO PART IS EXPECTED TO BE RETURNED. REPORTEDLY, THE DEVICE HAS BEEN TURNED OFF FOR A MONTH BEFORE THE EXPLANT PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.
IT WAS REPORTED THAT THE PATIENT'S PAIN HAD GOTTEN WORSE SINCE THE DEVICE WAS IMPLANTED. MAINSTAY MEDICAL REPRESENTATIVE CONTACTED THE IMPLANTING PHYSICIAN, WHO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PRESSING ON THE ILIAC CREST, CAUSING RADICULAR-LIKE SYMPTOMS. AN X-RAY, COMPUTED TOMOGRAPHY (CT) SCAN, AND MAGNETIC RESONANCE IMAGING (MRI) CONFIRMED THIS WAS NOT THE CASE. THE REACTIV8 SYSTEM WAS EXPLANTED. ALL PARTS WERE REMOVED AND INTACT. PER THE HOSPITAL'S PROTOCOL, NO PART IS EXPECTED TO BE RETURNED. REPORTEDLY, THE DEVICE HAS BEEN TURNED OFF FOR A MONTH BEFORE THE EXPLANT PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2150137 | REACTIV8 | REACTIV8 IMPLANTABLE PULSE GENERATOR | QLK | MAINSTAY MEDICAL LIMITED | 5100 | 05391527770015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Other |