MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-03-06 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[69166865]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[69166866]
Information was received from a consumer regarding a patient implanted with a neurostimulator (ins) for obsessive compulsive disorder. It was reported that the patient had been having trouble recharging for about six weeks prior to this report. It was reported that the patient was getting poor coupling. The day before this report, the patient had no bars, then got 2 or 4, and finally got all bars, but it took a long time to get full coupling. It was reported that it takes even longer to recharge the device now. The patient did not have their programmer at the time of this report, so no troubleshooting was performed. It was noted the patient would check the implant to confirm it was on. There was no indication of patient harm. A replacement recharging antenna was sent to the patient to see if that resolved the patient? S recharging issues. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[73371524]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[73371525]
Additional information was received. It was reported that the patient's healthcare professional (hcp) hadn't seen the patient since implant. It was noted that the hcp would have a manufacturer representative (rep) contact the patient. It was also noted that it may be time to replace the patient's battery. The rep reported that they were not sure if the patient's recharging issue was resolved. It was also unclear if the recharging or reduced battery capacity is the issue.
Patient Sequence No: 1, Text Type: D, B5
[74512507]
Patient Sequence No: 1, Text Type: N, H10
[74512508]
Follow up information received from the patient reported that they were sent a new antenna to resolve their issues with recharging, poor coupling, and taking longer than usual to recharge. It was noted that the issues have resolved, but they are still problematic. The patient stated that it was "perhaps" the old antenna malfunctioned, causing the issues, but they are unsure. No further complications are anticipated.
Patient Sequence No: 1, Text Type: D, B5
[101048186]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-00866 |
| MDR Report Key | 6380771 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-03-06 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-04-21 |
| Date Added to Maude | 2017-03-06 |
| 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 | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN IMPLANTABLE NEUROSTIMULATOR |
| Product Code | MFR |
| Date Received | 2017-03-06 |
| Model Number | NEU_INS_STIMULATOR |
| Catalog Number | NEU_INS_STIMULATOR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-06 |