MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37601

Device Problem Loss of Data (2903)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

Information was received from the manufacturer¿s representative (rep) who reported when interrogating the implantable neurostimulator (ins-activa) (two different tablets were used) they got the invalid data message, all settings will be cleared error code #00000b62 and the settings were cleared.It was confirmed the patient was set up in surgery at time of implant ((b)(6) 2021 and confirmed with multiple interrogations the implant was working fine).On november 4th the implant was being reprogrammed and interrogated multiples times with no issue.In addition, there had been multiple devices checked prior to and after this patient with no issues.The rep did notice the communicator that worked with the tablet needed to be updated (confirmed 1.0.1169 on communicator indicating upgrade was needed).Feature code 3x405f.It was noted the clinic saw 3,000 patients so the programmers were up to date.

Manufacturer Narrative

Other relevant device(s) are: product id a610 lot# serial# unknown implanted: explanted: product type software.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12787352
• MDR Text Key: 280591371
• Report Number: 3004209178-2021-16770
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/10/2021
• Date Device Manufactured: 02/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female