MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-29 for 424 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[98583891]
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[98583892]
It was reported that the physician used expired medical adhesive to address lead insulation damage on the rv lead. The physician elected to use the expired medical adhesive despite the advice of abbott representative. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[121765568]
Correction: the event date should have been (b)(6) 2017, rather than (b)(6) 2017.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2938836-2018-00905 |
| MDR Report Key | 7224923 |
| Date Received | 2018-01-29 |
| Date of Report | 2019-02-08 |
| Date of Event | 2017-12-21 |
| Date Mfgr Received | 2019-01-18 |
| Date Added to Maude | 2018-01-29 |
| 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 | ROBERT GREENLEAF |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8184932577 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Manufacturer Street | 645 ALMANOR AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | MEDICAL ADHESIVE |
| Product Code | MZR |
| Date Received | 2018-01-29 |
| Model Number | 424 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Manufacturer Address | 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-29 |