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

Model Number 37612

Device Problems Low impedance (2285); Delayed Charge Time (2586)

Patient Problems Discomfort (2330); Swelling/ Edema (4577)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Please note that this device was used in an off-label manner as it was implanted for dystonia.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had chest pocket swelling and tenderness.There are no known factors that may have led to this issue.The implantable neurostimulator (ins) was interrogated and a short circuit displayed between contacts 3 and 2.The patient stated her programming nurse told her about the short circuit ¿a long time ago.¿ she is programmed on contacts that do not include the short circuit combination.The ins had a charge of 75%.She was receiving therapy.After reporting the findings to the doctor, a resident evaluated the patient and the swelling had gone down.There was no fever.No further actions were taken and the patient was discharged.The issue was resolved.Additional information received from the manufacturer¿s representative (rep) reported that the cause of the short circuit wasn¿t determined, nor was the date for when the issue occurred.The cause of the longer charging duration wasn¿t determined and it wasn¿t clear if the longer recharging durations were related to increased therapy settings or pocket swelling.The healthcare provider (hcp) was going to speak with the patient about the issue, but no date had been scheduled.Due to this no steps had been taken to resolve the charging duration issue with average coupling being a 6/8 and it was unclear if the issue was resolved.

• 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: 12644434
• MDR Text Key: 276904396
• Report Number: 3004209178-2021-15453
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/17/2021
• Date Device Manufactured: 02/04/2015
• 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: 66 YR
• Patient Weight: 64