| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SWIFT-LOCK ANCHOR | SCS ANCHOR | ST. JUDE MEDICAL - NEUROMODULATION | GZB | 1192 | 1192 | 6342722 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-02 | 0 | 1. O |
Patient 1
THE EVENT DATE IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: MODEL: 3186 (X2), SCS LEADS, THERAPY DATE: UNKNOWN, MODEL:#: 1192, SCS ANCHOR, THERAPY DATE: UNKNOWN THE PATIENT'S WEIGHT WAS UNABLE TO BE OBTAINED. THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
Patient 1
DEVICE 4 OF 4; REFERENCE MFR. REPORT#: 3006705815-2020-01003; REFERENCE MFR. REPORT#: 3006705815-2020-01004; REFERENCE MFR. REPORT#: 1627487-2020-02352. IT WAS REPORTED ONE OF THE PATIENT'S LEADS HAD MIGRATED AND HIGH IMPEDANCE WAS PRESENT AS A RESULT. THE PATIENT LATER UNDERWENT SURGICAL INTERVENTION AND DURING THE PROCEDURE THE ANCHOR ASSOCIATED WITH THE LEAD THAT MIGRATED WAS FOUND TO BE BROKEN. IN TURN, THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE BOTH OF THE PATIENT'S LEADS AND ANCHORS TO ADDRESS THE ISSUE. NOTE: BOTH OF THE PATIENT'S LEADS AND ANCHORS ARE BEING REPORTED BECAUSE IT'S UNKNOWN WHICH DEVICES WERE LIABLE.
Patient 1
THE REPORTED EVENT OF BREAKAGE WAS CONFIRMED ON ONE OF THE RETURN ANCHORS. BOTH ANCHORS PASSED FUNCTIONAL TESTING. THE CAUSE OF THE BREAKAGE IS CONSISTENT WITH OVERSTRESS CONDITION THE ANCHOR WAS SUBJECTED WHILE IN VIVO.
Patient 1
DEVICE 4 OF 4: REFERENCE MFR. REPORT#: 3006705815-2020-01003. REFERENCE MFR. REPORT#: 3006705815-2020-01004. REFERENCE MFR. REPORT#: 1627487-2020-02352.