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

Model Number 37601

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Muscular Rigidity (1968); Neck Pain (2433)

Event Date 06/20/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2020, product type: extension.Product id :3708660, serial#: (b)(4), implanted: (b)(6) 2020, product type: extension.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient feels tightness at the extension site and the extensions are prominent when they turn their head.The patient has neck pain in the area prior to the implant.The patient was going to be seen on (b)(6) 2020.They are doing physical therapy till then.Additional information received from the healthcare provider (hcp) reported the cause of the issue was not 100% clear, but the generator appeared to have migrated upwards.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10755320
• MDR Text Key: 213703925
• Report Number: 3004209178-2020-18921
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000310332
• UDI-Public: 00763000310332
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2020
• Date Device Manufactured: 02/27/2020
• 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: 42 YR
• Patient Weight: 60