MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for ACCOLADE MRI DR L311 manufactured by Boston Scientific Corporation.
[185884144]
(b)(4). Cardiopulmonary resuscitation, performed. Records indicate this device remained implant. As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10
[185884145]
It was reported that following a lotus edge valve implant procedure, this patient became indicated for placement of a pacemaker. This device was successfully implanted and the pocket was closed without complication. At the end of the procedure the patient complained of back pain, dry mouth and her blood pressure dropped. The patient then went into cardiac arrest and cardiopulmonary resuscitation was performed. The patient's ventricular function was at 15% and patient was on a ventilator and non responsive. The patient was transferred to the intensive care unit where the their blood pressure dropped again. The patient was assessed and it was determined that the patient may have sustained brain damage. The family elected to remove ventilator support and the patient passed away within 10 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-06589 |
| MDR Report Key | 9907995 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-05-24 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 MRI DR |
| Generic Name | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
| Product Code | LWP |
| Date Received | 2020-03-31 |
| Model Number | L311 |
| Catalog Number | L311 |
| Lot Number | 426977 |
| 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. Death | 2020-03-31 |