REACTIV8
Report
- Report Number
- 3013017877-2024-00071
- Event Type
- Injury
- Date Received
- September 23, 2024
- Date of Event
- August 27, 2024
- Report Date
- December 30, 2024
- Manufacturer
- MAINSTAY MEDICAL LIMITED
- Product Code
- QLK
- UDI-DI
- 05391527770015
- PMA / PMN Number
- P190021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MML REFERENCE #: (B)(4). OTHER DEVICE EXPLANTED: MODEL: 8145. DESCRIPTION: PERCUTANEOUS STIMULATION LEADS. SERIAL NUMBERS: (B)(6). UDI: (B)(4).
MML REFERENCE #: (B)(4). OTHER DEVICE EXPLANTED: MODEL: 8145 DESCRIPTION: PERCUTANEOUS STIMULATION LEADS SERIAL NUMBERS: (B)(6). UDI: (B)(6). THE DEVICE WAS RETURNED AND EVALUATED. THERE WAS NO ALLEGATION AGAINST THE FUNCTIONALITY OF THE IPG AND LEADS. THE IPG PASSED FUNCTIONAL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. NO FUNCTIONAL TESTING COULD BE PERFORMED ON BOTH LEADS BECAUSE THEY WERE RECEIVED IN TWO SEGMENTS. A VISUAL INSPECTION WAS PERFORMED. NO RELEVANT NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE INFECTION. ALTHOUGH REQUESTED, THE RESULT OF THE PATHOLOGY TESTING WAS NOT PROVIDED TO MML. UPDATED B5, H6, AND IPG UDI. UPDATED THE INITIAL REPORTER'S NAME, AND DUE TO GENERAL DATA PROTECTION REGULATIONS IN THE UK, NO PATIENT INFORMATION IS AVAILABLE.
MML REFERENCE #: (B)(4). OTHER DEVICE EXPLANTED: MODEL: 8145. DESCRIPTION: PERCUTANEOUS STIMULATION LEADS. SERIAL NUMBERS: (B)(6). UDI: (B)(4). THE DEVICE WAS RETURNED AND EVALUATED. THERE WAS NO ALLEGATION AGAINST THE FUNCTIONALITY OF THE IPG AND LEADS. THE IPG PASSED FUNCTIONAL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. NO FUNCTIONAL TESTING COULD BE PERFORMED ON BOTH LEADS BECAUSE THEY WERE RECEIVED IN TWO SEGMENTS. A VISUAL INSPECTION WAS PERFORMED. NO RELEVANT NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE INFECTION. ALTHOUGH REQUESTED, THE RESULT OF THE PATHOLOGY TESTING WAS NOT PROVIDED TO MML.
IT WAS REPORTED THAT THE PATIENT HAD A POSITIVE RESPONSE TO THE THERAPY BUT HAD A RASH AND SWELLING AROUND THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS, BUT THE ISSUE PERSISTED, AND THEREFORE, THE PATIENT WAS SCHEDULED TO UNDERGO AN EXPLANT PROCEDURE DUE TO A SUSPECTED ALLERGIC REACTION TO THE DEVICE. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN CONFIRMED IT WAS AN INFECTION, NOT AN ALLERGIC REACTION TO THE DEVICE. THE DEVICE WAS EXPLANTED WITHOUT COMPLICATIONS, AND THE PATIENT WAS ALSO TREATED WITH DIRECT ANTIBIOTICS. THE RESULT OF THE PATHOLOGY TEST IS PENDING. THE DEVICE MANUFACTURING RECORD WAS REVIEWED. NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE INFECTION EXPERIENCED BY THE PATIENT.
IT WAS REPORTED THAT THE PATIENT HAD A POSITIVE RESPONSE TO THE THERAPY BUT HAD A RASH AND SWELLING AROUND THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS, BUT THE ISSUE PERSISTED, AND THEREFORE, THE PATIENT WAS SCHEDULED TO UNDERGO AN EXPLANT PROCEDURE DUE TO A SUSPECTED ALLERGIC REACTION TO THE DEVICE. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN CONFIRMED IT WAS AN INFECTION, NOT AN ALLERGIC REACTION TO THE DEVICE. THE DEVICE WAS EXPLANTED WITHOUT COMPLICATIONS, AND THE PATIENT WAS ALSO TREATED WITH DIRECT ANTIBIOTICS. THE DEVICE MANUFACTURING AND STERILIZATION RECORD WAS REVIEWED. NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE INFECTION EXPERIENCED BY THE PATIENT.
IT WAS REPORTED THAT THE PATIENT HAD A POSITIVE RESPONSE TO THE THERAPY BUT HAD A RASH AND SWELLING AROUND THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS, BUT THE ISSUE PERSISTED, AND THEREFORE, THE PATIENT WAS SCHEDULED TO UNDERGO AN EXPLANT PROCEDURE DUE TO A SUSPECTED ALLERGIC REACTION TO THE DEVICE. DURING THE EXPLANT PROCEDURE, THE PHYSICIAN CONFIRMED IT WAS AN INFECTION, NOT AN ALLERGIC REACTION TO THE DEVICE. THE DEVICE WAS EXPLANTED WITHOUT COMPLICATIONS, AND THE PATIENT WAS ALSO TREATED WITH DIRECT ANTIBIOTICS. THE DEVICE MANUFACTURING AND STERILIZATION RECORD WAS REVIEWED. NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE INFECTION EXPERIENCED BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1784720 | REACTIV8 | REACTIV8 IMPLANTABLE PULSE GENERATOR | QLK | MAINSTAY MEDICAL LIMITED | 5100 | 05391527770015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |