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 2020-03-14 for IPG(INTEGRATED, DUAL 8, 40CM) 71002 manufactured by Nalu Medical Inc..
| Report Number | 3015425075-2020-00002 |
| MDR Report Key | 9832597 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-14 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2018-11-05 |
| Date Added to Maude | 2020-03-14 |
| 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 | MR TERRY VILLARBA |
| Manufacturer Street | 2320 FARADAY AVENUE |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4482360 |
| Manufacturer G1 | NALU MEDICAL INC. |
| Manufacturer Street | 2320 FARADAY AVENUE |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IPG(INTEGRATED, DUAL 8, 40CM) |
| Generic Name | SPINAL CORD STIMULATOR |
| Product Code | GZB |
| Date Received | 2020-03-14 |
| Model Number | 71002 |
| Catalog Number | 71002 |
| Lot Number | NI |
| Device Expiration Date | 2019-11-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NALU MEDICAL INC. |
| Manufacturer Address | 2320 FARADY AVENUE CARLSBAD, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-14 |