MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Overheating of Device (1437); Delayed Charge Time (2586); Charging Problem (2892)

Patient Problem Burning Sensation (2146)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that caller was concerned about the staples on implant site, noting that the staples would get warm during recharge sessions.The caller stated that they were waiting for the incision to heal, and asked if the staples on implant site would cause an issue with recharging the ins.Agent reviewed information.The caller added that the ins had not reached a full charge since implant date (they mentioned the wr had not made the beeping tones that indicate a full charge), and that the recharger app would indicate that the ins battery was charging at 100% for "a whole hour" without the wr indicating the ins reached a full charge.The caller asked if that was normal, and if the reason the ins was not reaching a full charge was because patient's therapy settings were "pretty high." agent reviewed top-off mode and how the ins recharge rate slows down once the recharger app shows 'charging â¿¿ 100%.' agent reviewed difference between the recharger app screen that shows the ins charging and at 100% vs.The 'fully charged' screen.The c aller was dissatisfied with the way the recharger app does not show the exact battery percentage of the ins.They felt that it was confusing that the recharger app would show 100% when the ins battery was not actually charged to 100%.They mentioned looking in the wr manual for an explanation but were unable to find an answer.Agent reviewed that there was not an issue with the recharger app, and that was the way it was designed.Agent reviewed that the caller's feedback regarding the recharger app would be logged.The caller asked if the ins could be overcharged.Agent reviewed information.The caller mentioned that the percept pc was replaced with an activa rc (see rtg0162256 regarding reason for replacement).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 12978940
• MDR Text Key: 284209457
• Report Number: 3004209178-2021-18390
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• 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: 12/08/2021
• Date Device Manufactured: 08/23/2021
• 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 Sex: Female