MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for ACTIVA 37601 manufactured by Medtronic Puerto Rico Operations Co..
[185785834]
Upon receipt the ins was observed. Destructive analysis traced this to the electrically erasable programmable read-only memory (eeprom) on the hybrid circuit of the implantable neurostimulator (ins) resulting in a corrupt configuration file. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185785835]
Information was received from a manufacturer representative (rep) regarding a implantable neurostimulator (ins) to be implanted for deep brain stimulation (dbs) therapy. It was reported that prior to implant, the rep attempted to program the ins with the tablet programmer but while trying to connect an error message appeared on the tablet screen, "invalid data: invalid settings detected. All settings will be deleted. " the ins could not be programmed. Several attempts were made to connect with the ins without success. Another ins was used and was programmed without issue using the same tablet. There were no known external factors contributing to the event. There was no patient involvement. Additional information was received from a hcp. Device information was received. It was reported that the ins was later interrogated with the clinician programmer and the ins was able to be programmed, but it was not possible with the tablet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-06392 |
| MDR Report Key | 9898461 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-04-01 |
| Date of Event | 2019-09-18 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-07-02 |
| Date Added to Maude | 2020-03-30 |
| 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 | ACTIVA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MHY |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2019-10-01 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-30 |