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

Model Number 37602

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that the patient¿s implant was revised in 2013 and the physician removed the extension but left the lead wire in the brain.In (b)(6) 2014 the incision next to the connection kept oozing and weeping.The patient was reportedly hospitalized and given a pick line and 6 weeks of antibiotics.It was discovered that the patient had a quarter sized hole in his scalp with wires sticking out.The patient felt a crusting and oozing but didn¿t think anything of it.Culture from the parietal wound showed staph infection.It was reported that the infection perhaps remained in the lead wire that was left in.Perioperative antibiotics were given and the implantable neurostimulator and extension was removed on (b)(6) 2014 and replaced.During follow up on (b)(6) 2014 there was no drainage and the wound was healing.During follow up on (b)(6) 2015 erosion was noted over the wire.Actions required as a result of the event consisted of complete system removal.Pocket erosion and incisional wound opening was noted.The patient was noted to have ongoing symptoms.No outcomes were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id: 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: lead.Product id: 7482a51, serial# (b)(4) implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension.Product id: 748351, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 3387s-40, lot# va06jgn, implanted: (b)(6) 2013, product type: lead.Product id: 748351, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.(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: 4815698
• MDR Text Key: 5924080
• Report Number: 3004209178-2015-10212
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2015
• Date Device Manufactured: 09/23/2013
• 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: 00062 YR