INGEVITY
Report
- Report Number
- 2124215-2024-58554
- Event Type
- Injury
- Date Received
- September 18, 2024
- Date of Event
- July 13, 2024
- Report Date
- February 27, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- PMA / PMN Number
- P150012/S083
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED FOR ANALYSIS. THE ALLEGATION AGAINST THE PRODUCT WAS NOT CONFIRMED AS THE REPORTED ALLEGATIONS OF INFECTION WERE KNOWN INHERENT RISK OF DEVICE. ANALYSIS OF THE RETURNED PRODUCT WAS NOT ABLE TO PROVIDE RELEVANT INFORMATION FOR INFECTION-RELATED ALLEGATIONS. THIS SUPPLEMENTAL REPORT WAS BEING FILED TO CORRECT THE G4: BSC AWARE DATE (ADDITIONAL INFORMATION AWARE DATE), H3: DEVICE EVALUATION BY MANUFACTURER AND DEVICE NOT EVAL BY MFR CODE, AND H10: ADDITIONAL MFR NARRATIVE. THIS REPORT IS BEING FILED TO REMOVE INCORRECT PATIENT CODES E060104 AND E060109 (H6) AS THEY WERE UNRELATED TO THIS EVENT.
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED FOR ANALYSIS. THE ALLEGATION AGAINST THE PRODUCT WAS NOT CONFIRMED AS THE REPORTED ALLEGATIONS OF INFECTION WERE KNOWN INHERENT RISK OF DEVICE. ANALYSIS OF THE RETURNED PRODUCT WAS NOT ABLE TO PROVIDE RELEVANT INFORMATION FOR INFECTION-RELATED ALLEGATIONS. THIS SUPPLEMENTAL REPORT WAS BEING FILED TO CORRECT THE G4: BSC AWARE DATE (ADDITIONAL INFORMATION AWARE DATE), H3: DEVICE EVALUATION BY MANUFACTURER AND DEVICE NOT EVAL BY MFR CODE, AND H10: ADDITIONAL MFR NARRATIVE. THIS REPORT IS BEING FILED TO REMOVE INCORRECT PATIENT CODES E060104 AND E060109 (H6) AS THEY WERE UNRELATED TO THIS EVENT.
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED FOR ANALYSIS. THE ALLEGATION AGAINST THE PRODUCT WAS NOT CONFIRMED AS THE REPORTED ALLEGATIONS OF INFECTION WERE KNOWN INHERENT RISK OF DEVICE. ANALYSIS OF THE RETURNED PRODUCT WAS NOT ABLE TO PROVIDE RELEVANT INFORMATION FOR INFECTION-RELATED ALLEGATIONS. THIS SUPPLEMENTAL REPORT WAS BEING FILED TO CORRECT THE G4: BSC AWARE DATE (ADDITIONAL INFORMATION AWARE DATE), H3: DEVICE EVALUATION BY MANUFACTURER AND DEVICE NOT EVAL BY MFR CODE, AND H10: ADDITIONAL MFR NARRATIVE.
IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INFECTION. REPORTEDLY, THE PATIENT WAS PREVIOUSLY ADMITTED DUE TO DIZZINESS AND TACHYCARDIA-BRADYCARDIA SYNDROME (TBS) THEN A PACEMAKER WAS IMPLANTED. FURTHERMORE, THE PATIENT WAS READMITTED DUE TO A DEVELOPED SPEAKING DIFFICULTY, WHOLE BODY WEAKNESS, AND LEFT FACE FELT DROOPY. ADDITIONALLY, THE PATIENT ALSO HAD PURULENT DISCHARGE AND APHASIA. A REVISION WAS PERFORMED AND THE PACEMAKER ALONG WITH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS RETURNED.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. REPORTEDLY, THE PATIENT WAS PREVIOUSLY ADMITTED DUE TO DIZZINESS AND TACHYCARDIA-BRADYCARDIA SYNDROME (TBS). FURTHERMORE, THE PATIENT WAS READMITTED DUE TO A DEVELOPED SPEAKING DIFFICULTY, WHOLE BODY WEAKNESS, AND LEFT FACE FELT DROOPY. ADDITIONALLY, THE PATIENT ALSO HAD PURULENT DISCHARGE AND APHASIA. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. REPORTEDLY, THE PATIENT WAS PREVIOUSLY ADMITTED DUE TO DIZZINESS AND TACHYCARDIA-BRADYCARDIA SYNDROME (TBS). FURTHERMORE, THE PATIENT WAS READMITTED DUE TO A DEVELOPED SPEAKING DIFFICULTY, WHOLE BODY WEAKNESS, AND LEFT FACE FELT DROOPY. ADDITIONALLY, THE PATIENT ALSO HAD PURULENT DISCHARGE AND APHASIA. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS PART OF THE SYSTEM REVISION DUE TO INFECTION. REPORTEDLY, THE PATIENT WAS PREVIOUSLY ADMITTED DUE TO DIZZINESS AND TACHYCARDIA-BRADYCARDIA SYNDROME (TBS). FURTHERMORE, THE PATIENT WAS READMITTED DUE TO A DEVELOPED SPEAKING DIFFICULTY, WHOLE BODY WEAKNESS, AND LEFT FACE FELT DROOPY. ADDITIONALLY, THE PATIENT ALSO HAD PURULENT DISCHARGE AND APHASIA. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RV LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2524610 | INGEVITY | IMPLANTABLE LEAD | NVN | BOSTON SCIENTIFIC CORPORATION | 7841 | 1291215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Hospitalization| R |