MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for INTERSTIM II 3058 manufactured by Medtronic Puerto Rico Operations Co..
[186045502]
Concomitant medical products: product id: 3889-33, lot#: va1ltuy, implanted: (b)(6) 2018, product type: lead. Other relevant device(s) are: product id: 3889-33, serial/lot #: (b)(4), ubd: 13-nov-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186045503]
Information was received from a healthcare provider via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim. It was reported that the patient had an mri of the brain, but also needed an mri of the back. The healthcare provider explanted the ins and attempted to explant the lead. The partial lead was left in the patient's body. The rep did not know how much of the lead was left in the body, but believes that it was the distal end of the electrode. The rep wanted to know if there were recommendations for a full body mri, as he would share that information with the radiologist. An email was sent to medical affairs regarding mri compatibility. Medical affairs provided the healthcare provider with information regarding the lead fragments and mri. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[188154754]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188943238]
Product id 3889-33, lot# va1ltu, implanted: (b)(6) 2018, explanted: (b)(6) 2020. Product type lead. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188943239]
Additional information was received from a manufacturer representative. It was reported that the ins and lead were explanted on (b)(6) 2020. The patient's weight at the time of the event was unknown. There was no cause or reason that the partial lead was left in the patient. It was attempted to be fully removed and a small portion of the distal end fragmented. No action will be taken to remove the partial lead from the patient's body. The device and lead would not be returned, because the account discarded them. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06306 |
| MDR Report Key | 9892167 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-19 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2017-12-02 |
| Date Added to Maude | 2020-03-27 |
| 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 | INTERSTIM II |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE |
| Product Code | EZW |
| Date Received | 2020-03-27 |
| Model Number | 3058 |
| Catalog Number | 3058 |
| Device Expiration Date | 2019-05-28 |
| 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 | 2020-03-27 |