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 Erythema (1840); Skin Erosion (2075)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient's implantable neurostimulator (ins).It was reported the neurostimulator migrated/shifted and there was impeding skin erosion over the generator site.It was reported the issue was not related to the device, therapy, or implant procedure.Patient lost quite a bit of weight and she gained some of the weight back and with this, she developed a fat pad over the generator while the generator itself shifted within the pocket.In addition to that, she fell last week and injured the area of the generator exactly where it was protruding under the skin.There was confirmed presence of redness and thinning of skin over the lateral inferior aspect of the generator itself.The issue resulted in surgical intervention.The device was explanted and replaced/revised on (b)(6) 2019.The issue resolved without sequelae (b)(6) 2019.No further complications were reported or anticipated.

Event Description

Additional information was received from the manufacturer representative (rep) clarifying the explant/replacement occurred on (b)(6) 2019.Additional information was received from the hcp stating the event was related to the device or therapy.

Manufacturer Narrative

Aware date is 2019-jan-28.If information is provided in the future, a supplemental report will be issued.

• 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 MN 00777 1200
• MDR Report Key: 8293217
• MDR Text Key: 134609726
• Report Number: 3007566237-2019-00250
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

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: 02/28/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 97