MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for SPRINT QUATTRO SECURE S MRI SURESCAN 6935M62 manufactured by Medtronic Singapore Operations.
[185941061]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185941062]
It was reported that the patient collapsed due to a right ventricular (rv) lead perforation and resulting pericardial effusion. The right ventricular (rv) lead had exhibited a slow rise and variable thresholds since implant. During the lead revision procedure, it was noted that there appeared to be blood in the lumen in several spots. The effusion was drained and the lead was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188937994]
Product event summary: the full lead was returned and analyzed. Analysis indicated there was blood on the distal conductor of the lead and it was not obstructed. The inner insulation of the lead was extrinsically breached due to a cut. The outer insulation of the lead was extrinsically breached due to a cut. The overlay tubing of the lead was extrinsically breached due to a cut. The inner tubing of the lead was observed to have blood ingression. The overlay tubing of the lead was observed to have blood ingression. Visual analysis of the lead indicated damage at implant. The analyst noted there was blood visible inside of the lead body and on the distal conductor. Visual inspection found the insulation breach from the overlay tubing through the inner insulation causing the distal conductor to expose and that allows blood ingress into lead and on distal conductor. According to the finding and the anomalies described in the event, and due to the length of time of the implant, it is likely that the extrinsic insulation breach was contribute to the electrical complaints and caused at time of implant procedure. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008973940-2020-00775 |
| MDR Report Key | 9904045 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-01-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC SINGAPORE OPERATIONS |
| Manufacturer Street | 49 CHANGI SOUTH AVENUE 2 NASACO TECH CENTRE |
| Manufacturer City | SINGAPORE 486056 |
| Manufacturer Country | SG |
| Manufacturer Postal Code | 486056 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPRINT QUATTRO SECURE S MRI SURESCAN |
| Generic Name | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER |
| Product Code | LWS |
| Date Received | 2020-03-31 |
| Model Number | 6935M62 |
| Catalog Number | 6935M62 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SINGAPORE OPERATIONS |
| Manufacturer Address | 49 CHANGI SOUTH AVENUE 2 NASACO TECH CENTRE SINGAPORE 486056 SG 486056 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-31 |