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 2020-03-09 for EXTENSION, 30CM 3383 manufactured by St. Jude Medical - Neuromodulation.
[182699555]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[182699556]
Related manufacturer reference number: 1627487-2020-02552; related manufacturer reference number: 1627487-2020-02554; related manufacturer reference number: 3006705815-2020-01089. It was reported that the patient? S stimulation kept stopping on its own. Additionally, patient reported sometimes experiencing electrical sensations at the lead/extension connection site. Diagnostics revealed high impedances. X-ray revealed that one of the lead tails was not completely inserted into the extension. Reprogramming was unable to resolve the issue. As such, surgical intervention took place on (b)(6) 2020. During intra-op, impedance reading was normal on the lead and extension. However, the impedance reading was high when measured on the entire system. The extensions were replaced with new extensions, but the issue persisted. In turn, the ipg was also explanted and replaced with a ipg to address the issue. No intervention took place on the lead.
Patient Sequence No: 1, Text Type: D, B5
[182809258]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[182809259]
Additional information received indicates that the physician experienced difficulty inserting the new extensions into the ipg and the high impedance persisted. In turn, the ipg was also explanted and replaced with a ipg resolving the issue. Reportedly therapy was resumed.
Patient Sequence No: 1, Text Type: D, B5
[187480209]
The reported event for intermittent stimulation was not confirmed. At receipt, both extension lead have no anomaly and passed functional testing. No root cause was identified for the reported issue
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1627487-2020-02553 |
| MDR Report Key | 9809127 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2016-09-13 |
| Date Added to Maude | 2020-03-09 |
| 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 | EXTENSION, 30CM |
| Generic Name | SCS EXTENSION |
| Product Code | GZB |
| Date Received | 2020-03-09 |
| Model Number | 3383 |
| Catalog Number | 3383 |
| Lot Number | 5637822 |
| Device Expiration Date | 2018-09-13 |
| 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 | 2020-03-09 |