MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for SUB Q ARRAY 0085 manufactured by Boston Scientific Corporation.
[186514055]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186514056]
It was reported that this right ventricular (rv) defibrillation lead exhibited shock impedance measurements of greater than 125 ohms. A commanded shock was performed at 1. 1 joules resulting in shock impedances of 96 ohms in triad configuration. A commanded shock was performed at 41 joules resulting in shock impedances of greater than 125 ohms. The patients device had a subsequent code 1005 which is indicative of an open circuit condition was detected during shock delivery. A successful defibrillation threshold test (dft) was performed at 31 joules resulting in a shock impedance measurement of 106 ohms. A painless shock test was then performed in which a shock impedance measurement of 103 ohms was measured. At this time the physician planned to wait to replace the entire device system. The lead remains in service. No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-02909 |
| MDR Report Key | 9901627 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | CPI - DEL CARIBE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUB Q ARRAY |
| Generic Name | IMPLANTABLE LEAD |
| Product Code | LWS |
| Date Received | 2020-03-30 |
| Model Number | 0085 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |