MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-03-06 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.
[69166019]
Patient Sequence No: 1, Text Type: N, H10
[69166020]
Information was received from a consumer regarding a patient implanted with a neurostimulator (ins) for obsessive compulsive disorder. It was reported that since implant the patient has experienced little jolts here and there. It was also reported that it has taken a long time recharge the device since implant. It was stated the patient was not feeling stimulation and usually does not feel it. It was reported that the patient has never really felt stimulation since implant. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[73369395]
Patient Sequence No: 1, Text Type: N, H10
[73369396]
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.
Patient Sequence No: 1, Text Type: D, B5
[74509550]
Patient Sequence No: 1, Text Type: N, H10
[74509551]
Follow up information received from the patient reported that periodic jolting still occurs, which they assume is from the implant. It was also noted that it still takes longer to charge but that is because settings are high. No further complications are anticipated.
Patient Sequence No: 1, Text Type: D, B5
[101371959]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-00864 |
| MDR Report Key | 6380459 |
| Report Source | CONSUMER |
| Date Received | 2017-03-06 |
| Date of Report | 2017-04-25 |
| Date of Event | 2010-02-12 |
| 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 |