MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

It was reported the patient had skin discoloration.It was stated they had been in the hospital for 5 days and no one could determine the cause of the red markings.It was stated the patient had gone through a surgical exploration to culture the battery and extension but found nothing.It was stated the patient experienced red marks along the length of the extension.It was stated the patient had no symptoms other than red marks on the skin.It was noted it was not itchy, not hot, and no fever was present.It was stated surgical intervention was required as an intervention.It was noted intra-operative cultures were taken to full-out infection.It was noted all of the cultures were negative.It was stated the patient status at the time of report was unobtainable.It was stated the patient had red marks on their skin at the extension location.It was further reported there was an infection.It was noted around (b)(6) 2014 the patient had started to show signs of infection.It was stated they had blotches on their skin.It was noted when they were hospitalized for 5 days no infection was found.It was stated since then the blotches had gone away.It was noted it was still ¿up in the air¿ to what had caused the blotches.It was stated the patient was going to see another doctor for a second opinion.Additional information received reported the patient was very satisfied with the therapy but was still concerned about the marks.It was noted nothing was explanted.

Manufacturer Narrative

Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va0fge1, implanted: (b)(6) 2014, product type: lead; product id 3387s-40, lot# va0fge1, implanted: (b)(6) 2014, product type: lead.(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3824045
• MDR Text Key: 4391086
• Report Number: 3004209178-2014-09343
• Device Sequence Number: 1
• Product Code: MHY
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2014
• Date Device Manufactured: 12/12/2013
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00071 YR