REACTIV8
Report
- Report Number
- 3021520203-2024-00028
- Event Type
- Injury
- Date Received
- January 4, 2025
- Date of Event
- December 5, 2024
- Report Date
- March 17, 2025
- Manufacturer
- MAINSTAY MEDICAL LIMITED
- Product Code
- QLK
- UDI-DI
- 05391527770015
- PMA / PMN Number
- P190021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MML # (B)(4). OTHER DEVICE EXPLANTED. MODEL: 8145 DESCRIPTION: IMPLANTABLE STIMULATION LEADS SERIAL NUMBERS: (B)(6). UDIS: (B)(4).
MML # (B)(4). OTHER DEVICE EXPLANTED. MODEL: 8145. DESCRIPTION: IMPLANTABLE STIMULATION LEADS. SERIAL NUMBERS: (B)(6). UDIS: (B)(4). THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD ASSEMBLIES WERE RETURNED FOR ANALYSIS. THE IPG PASSED THE FUNCTIONAL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. BOTH LEADS WERE RECEIVED IN TWO SEGMENTS. THEREFORE, NO FUNCTIONAL TESTING OF THE DEVICE CAN BE CARRIED OUT. VISUAL INSPECTION OF THE IPG AND LEADS FOUND NO ANOMALIES RELEVANT TO THE SUSPECTED INFECTION. THE DEVICE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED. ALL PASSED THE STERILIZATION PROCESS, AND NO OBSERVATION WOULD HAVE CONTRIBUTED TO THE ALLEGED INFECTION.
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF WARMTH TO THE BATTERY SITE AND DRAINAGE FROM THE CAUDAL EDGE OF THE MIDLINE INCISION. THE PATIENT REPORTED THAT THE EVENT HAD HAPPENED ON THREE DIFFERENT OCCASIONS: AT FOUR WEEKS POST-OP AND WAS TREATED WITH ANTIBIOTICS, THEN AT 5-6 MONTHS AND 10 MONTHS. THUS FAR, INCREMENTAL VISITS WITH THE MAINSTAY MEDICAL LIMITED (MML) REPRESENTATIVE AND PATIENT THERAPY HAVE BEEN WITHIN NORMAL LIMITS, AND THE PATIENT REPORTED SEEING MODERATE FUNCTIONAL IMPROVEMENT. IN THE THIRD INSTANCE OF DRAINAGE TO INCISION COMPLAINTS, THE MEDICAL DOCTOR ASKED THE MML REPRESENTATIVE TO ASSESS THE PATIENT'S THERAPY SETTINGS. THE MML REPRESENTATIVE ASSESSES THE REACTIV8 BY PERFORMING INTERROGATION, IMPEDANCE MATRIX, DATA GRAPH, AND IPG. ALL ARE WITHIN NORMAL LIMITS DURING THE VISIT. THE IPG WAS TURNED OFF FOR 10 MINUTES, AND THE PATIENT REPORTED NO DIFFERENCE IN THE WARMTH TO THE BATTERY SITE. SKIN TO TOUCH AT THE LEFT FLANK BATTERY SITE WAS WARMER THAN THE SKIN ON THE RIGHT FLANK OF THE PATIENT, WHICH REMAINED THE SAME THROUGHOUT THE VISIT WITH AND WITHOUT A SESSION RUNNING. THERE WAS NO VISIBLE DRAINAGE DURING THE MML VISIT. A CULTURE WAS TAKEN DURING THE FOLLOW-UP VISIT WITH THE MEDICAL DOCTOR. THE CULTURE RESULT RETURNED NEGATIVE FOR INFECTION, AND THE PATIENT WAS CLEARED TO START DOING TWO THERAPY SESSIONS AGAIN DAILY. IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED. WHILE THE MEDICAL DOCTOR WAS MAKING THE INCISION, THE DOCTOR CONFIRMED AN INFECTION BECAUSE OF THE ABSCESS IN THE BATTERY SITE. THE DEVICE WAS EXPLANTED ENTIRELY WITHOUT COMPLICATIONS.
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF WARMTH TO THE BATTERY SITE AND DRAINAGE FROM THE CAUDAL EDGE OF THE MIDLINE INCISION. THE PATIENT REPORTED THAT THE EVENT HAD HAPPENED ON THREE DIFFERENT OCCASIONS: AT FOUR WEEKS POST-OP AND WAS TREATED WITH ANTIBIOTICS, THEN AT 5-6 MONTHS AND 10 MONTHS. THUS FAR, INCREMENTAL VISITS WITH THE MAINSTAY MEDICAL LIMITED (MML) REPRESENTATIVE AND PATIENT THERAPY HAVE BEEN WITHIN NORMAL LIMITS, AND THE PATIENT REPORTED SEEING MODERATE FUNCTIONAL IMPROVEMENT. IN THE THIRD INSTANCE OF DRAINAGE TO INCISION COMPLAINTS, THE MEDICAL DOCTOR ASKED THE MML REPRESENTATIVE TO ASSESS THE PATIENT'S THERAPY SETTINGS. THE MML REPRESENTATIVE ASSESSES THE REACTIV8 BY PERFORMING INTERROGATION, IMPEDANCE MATRIX, DATA GRAPH, AND IPG. ALL ARE WITHIN NORMAL LIMITS DURING THE VISIT. THE IPG WAS TURNED OFF FOR 10 MINUTES, AND THE PATIENT REPORTED NO DIFFERENCE IN THE WARMTH TO THE BATTERY SITE. SKIN TO TOUCH AT THE LEFT FLANK BATTERY SITE WAS WARMER THAN THE SKIN ON THE RIGHT FLANK OF THE PATIENT, WHICH REMAINED THE SAME THROUGHOUT THE VISIT WITH AND WITHOUT A SESSION RUNNING. THERE WAS NO VISIBLE DRAINAGE DURING THE MML VISIT. A CULTURE WAS TAKEN DURING THE FOLLOW-UP VISIT WITH THE MEDICAL DOCTOR. THE CULTURE RESULT RETURNED NEGATIVE FOR INFECTION, AND THE PATIENT WAS CLEARED TO START DOING TWO THERAPY SESSIONS AGAIN DAILY. IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED. WHILE THE MEDICAL DOCTOR WAS MAKING THE INCISION, THE DOCTOR CONFIRMED AN INFECTION BECAUSE OF THE ABSCESS IN THE BATTERY SITE. THE DEVICE WAS EXPLANTED ENTIRELY WITHOUT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1310801 | REACTIV8 | REACTIV8 IMPLANTABLE PULSE GENERATOR | QLK | MAINSTAY MEDICAL LIMITED | 5100 | 05391527770015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | Other |