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 2019-05-02 for QUATTRODE LEAD WIDE SPACED, 60 CM 3166 manufactured by St. Jude Medical - Neuromodulation.
[143852037]
Investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[143852038]
Device 1 of 4. Reference mfr. Report#: 1627487-2019-05185. Reference mfr. Report#: 1627487-2019-05186. Reference mfr. Report# 1627487-2019-05187. It was reported that one of the patient's lead had high impedance. Reprogramming was unable to resolve the issue. As a result, surgical intervention may be planned to address the issue. It is unknown which lead is related to the issue. Therefore, all the suspected devices are being reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1627487-2019-05238 |
| MDR Report Key | 8574254 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-02 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2019-11-13 |
| Device Manufacturer Date | 2011-11-15 |
| Date Added to Maude | 2019-05-02 |
| 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 | ANDREA DEITZ |
| Manufacturer Street | 6901 PRESTON ROAD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal | 75024 |
| Manufacturer Phone | 9723098000 |
| Manufacturer G1 | ST. JUDE MEDICAL - NEUROMODULATION |
| Manufacturer Street | 6901 PRESTON RD |
| Manufacturer City | PLANO TX 75024 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUATTRODE LEAD WIDE SPACED, 60 CM |
| Generic Name | PNS LEAD |
| Product Code | GZF |
| Date Received | 2019-05-02 |
| Model Number | 3166 |
| Lot Number | 3547072 |
| Device Expiration Date | 2013-11-28 |
| 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 - NEUROMODULATION |
| Manufacturer Address | 6901 PRESTON RD PLANO TX 75024 US 75024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-02 |