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

Model Number 7426

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Discomfort (2330); Complaint, Ill-Defined (2331); Impaired Healing (2378)

Event Type  Injury  

Event Description

It was reported that around 2011 the patient had bumped his head where the deep brain stimulator was located.The patient had a scuff there that had seemed to heal but a short time later had become red and sore.The patient saw a physician assistant for the redness and soreness and they were going to keep an eye on it to see if it healed.The wound went back and forth from healing to not healing so the physician assistant sent the patient to doctor.The doctor had seemed concerned and they opened up the wound in an attempt to heal the infection and then re-stitched it closed and the patient was put on a very strong antibiotic in hopes of the wound healing.The wound did not heal as they had hoped and the wires were exposed the next time the patient had seen the doctor and the infection was not healed.The doctor then made the decision to remove the left device due to the infection.The skin where the implant was located was very thin with poor blood supply and he thought that contributed to the fact that they could not get the infection and wound to heal properly.

Manufacturer Narrative

Concomitant products: product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, product type: extension.Product id: 3387-40, lot# v004231, implanted: (b)(6) 2006, product type: lead.Product id: 3387-40, lot# v004231, implanted: (b)(6) 2006, product type: lead.Product id: 7426, serial# (b)(4), product type: implantable neurostimulator.Product id: 3387-40, lot# v004231, implanted: (b)(6) 2006, product type: lead.(b)(4).

• Brand Name: SOLETRA
• 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: 4928804
• MDR Text Key: 6051306
• Report Number: 3004209178-2015-13759
• 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: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2011
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2015
• Date Device Manufactured: 08/28/2009
• 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): Required Intervention
• Patient Age: 00077 YR