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

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Swelling/ Edema (4577)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

It was reported that the patient could not get the wireless recharger (wr) to maintain a good connection with the implanted neurostimulator (ins), noting that the wr would start beeping if the wr moved a little bit.As a result, the patient stated that it took a long time for the wr to charge the ins.The patient added that they could not get the drape to work because it would not stay balanced over the ins.The patient mentioned that they were trained on how to use the wr on implant date, but they were "so loopy" that they did not retain much of their training.During the call, the patient checked their ins battery level using the patient programmer (model 37642) and reported that the ins battery level was at 75%.The patient then started a recharge session, but the wr kept beeping continuously.Agent reviewed that the continuous beeping indicated that the wr was searching for the ins.At times, agent could hear the wr make a connection to the ins for a few seconds at a time, but then it would revert to beeping and searching for the ins.The patient denied having any bandages over the ins site, but they did mention that they have sutures that will be taken out next tuesday.The patient also noted that the ins site did have a "little bit" of swelling.During the call, the patient palpated the ins and mentioned that they could physically move the ins, but confirmed that it remained in place when they were not palpating it.However, the patient was able to get the wr to maintain a connection with the ins after removing their shirt and positioning the wr so the 2 circles on the drape pocket were an inch above the ins site.Agent reviewed that the ins site would likely require more time to heal, and advised the patient to follow up with their managing healthcare provider with any concerns regarding the ins site.

Manufacturer Narrative

Concomitant medical products: product id: wr9200, serial# (b)(4), product type: recharger.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: 12914035
• MDR Text Key: 285624242
• Report Number: 3004209178-2021-17875
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2021
• Date Device Manufactured: 08/18/2021
• 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: 65 YR
• Patient Sex: Male