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 2019-02-28 for INTELLIS 97715 manufactured by Medtronic Puerto Rico Operations Co..
[138561761]
Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2018, product type: lead. Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 10-jul-2022, (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 10-jul-2022, (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[138561762]
Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins). The consumer reported that? The last week of november? The patient? S lead wire? Changed position? Due to the? Healing process? So a manufacturer? S representative (rep) reprogrammed the patient. The consumer also reported how? Phenomenally successful? The patient? S therapy had been. Additional information was received from a rep. The rep reported that the cause of the lead changing position was unknown; slight lead migration as the lead healed in. The rep reported that no action was needed. The issue was resolved. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2019-04199 |
| MDR Report Key | 8377606 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-02-28 |
| Date of Report | 2019-02-28 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-02-01 |
| Device Manufacturer Date | 2018-08-16 |
| Date Added to Maude | 2019-02-28 |
| 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 PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELLIS |
| Generic Name | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Product Code | LGW |
| Date Received | 2019-02-28 |
| Model Number | 97715 |
| Catalog Number | 97715 |
| Device Expiration Date | 2019-08-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-28 |