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 ACCOLADE EL DR L321 manufactured by Boston Scientific Corporation.
[186286856]
(b)(4). This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted. The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.
Patient Sequence No: 1, Text Type: N, H10
[186286857]
It was reported that this pacemaker and a non boston scientific right ventricular (rv) lead exhibited loss of capture with pauses of greater than two seconds, and impedance measurements of greater than 3000 ohms. The patient had symptoms of dizziness and had a heart rate in the 25 to 30 beats per minute (bpm) range. A temporary pacing wire was used, and the device was reprogrammed. No additional adverse patient effects were reported. The device remains in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-02374 |
| MDR Report Key | 9901628 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2015-04-01 |
| 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 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCOLADE EL DR |
| Generic Name | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
| Product Code | LWP |
| Date Received | 2020-03-30 |
| Model Number | L321 |
| Catalog Number | L321 |
| Lot Number | 700738 |
| Device Expiration Date | 2017-04-01 |
| 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. Required No Informationntervention | 2020-03-30 |