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 2020-03-26 for INTERSTIM II 3058 manufactured by Medtronic Puerto Rico Operations Co..
[188144507]
Product id 3058, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2020. Product type implantable neurostimulator. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188144508]
No new information.
Patient Sequence No: 1, Text Type: D, B5
[188588538]
This event was also reported under manufacturer report #3004209178-2020-06220. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188588539]
Information was received from a healthcare professional via a manufacturer representative 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 a bilateral sns device implanted for several years. The skin directly above the implanted ins on the left side began to erode over the last several months. The physician suspects there was an issue with the ins that caused the skin erosion and would like the device analyzed. The physician performed a battery replacement procedure on the patient (both left and right). Upon dissection, the physician found a non-infected seroma above the battery pocket. The physician explanted the old devices in question and implanted new ins. The issue was resolved. The following day, the patient called stating that he has 2 ins and the one on the left side started protruding, shifted, and turned purple. When ask, the patient said that he has memory problems and unable to provide any type of timeframe of when this change was first noticed. The patient said that he didhave a revision/replacement yesterday and they moved the one that was on the left side to the other side. The patient said that he does not have a current managing doctor as his doctor is being deployed. The patient would like an adjustment and insists that the manufacturer representative (rep) has to do it however, said he does not have her number. The field contact present during the replacement was contacted. No further patient complications are anticipated or expected as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06221 |
| MDR Report Key | 9885604 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2015-01-16 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | 3058 |
| Catalog Number | 3058 |
| Device Expiration Date | 2016-07-14 |
| 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 | 1. Required No Informationntervention | 2020-03-26 |