REACTIV8
Report
- Report Number
- 3013017877-2024-00064
- Event Type
- Injury
- Date Received
- September 6, 2024
- Date of Event
- December 11, 2023
- Report Date
- December 19, 2024
- Manufacturer
- MAINSTAY MEDICAL LIMITED
- Product Code
- QLK
- PMA / PMN Number
- P190021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MML REFERENCE #: (B)(4). OTHER DEVICES EXPLANTED: MODEL: 8145, DESCRIPTION: REACTIV8 IMPLANTABLE STIMULATION LEADS, SERIAL NUMBERS: (B)(6), UDI: (B)(4). THE DEVICES WERE RECEIVED AND EVALUATED. THERE WAS NO ALLEGATION AGAINST THE FUNCTIONALITY OF THE EXPLANTED DEVICES. THE IPG PASSED THE FUNCTIONAL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS A VISUAL INSPECTION WAS CARRIED OUT ON THE IPG. NO ANOMALIES OR OBSERVATIONS WERE IDENTIFIED. NO FUNCTIONAL TESTING COULD BE DONE ON THE LEADS BECAUSE THEY WERE DAMAGED FROM THE EXPLANT. THE MANUFACTURING RECORDS FOR THE IPG AND LEADS WERE REVIEWED, AND NO RELEVANT NONCONFORMANCES WERE FOUND.
MML REFERENCE (B)(4). OTHER DEVICES EXPLANTED: MODEL: 8145. DESCRIPTION: STIMULATION LEAD: SERIAL NUMBERS: (B)(6), UDI:(B)(4).
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT ON THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE AND WANTS THE DEVICE REMOVED. REPORTEDLY, THE PATIENT HAS INCREASING NEUROPATHIC PAIN BILATERAL TO LOWER LIMBS AND LEGS NOT ASSOCIATED WITH THE IMPLANTED DEVICE AND WANTS THE DEVICE REMOVED TO SEEK OTHER OPTIONS FOR NEUROPATHIC PAIN. THE DEVICE WAS REMOVED. HOWEVER, THE SURGEON PROCEEDED WITH MANUAL EXTRACTION THAN THE TOOL TO EXPLANT THE LEADS, AND THEREFORE, THE DISTAL ELECTRODE ON THE RIGHT LEAD AND SOME LEAD FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT ON THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE AND WANTS THE DEVICE REMOVED. REPORTEDLY, THE PATIENT HAS INCREASING NEUROPATHIC PAIN BILATERAL TO LOWER LIMBS AND LEGS NOT ASSOCIATED WITH THE IMPLANTED DEVICE AND WANTS THE DEVICE REMOVED TO SEEK OTHER OPTIONS FOR NEUROPATHIC PAIN. THE DEVICE WAS REMOVED. HOWEVER, THE SURGEON PROCEEDED WITH MANUAL EXTRACTION THAN THE TOOL TO EXPLANT THE LEADS, AND THEREFORE, THE DISTAL ELECTRODE ON THE RIGHT LEAD AND SOME LEAD FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1346500 | REACTIV8 | REACTIV8 IMPLANTABLE PULSE GENERATOR | QLK | MAINSTAY MEDICAL LIMITED | 5100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Male | Other |