MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

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

Patient Problems Wound Dehiscence (1154); Swelling (2091); Sweating (2444); Fluid Discharge (2686)

Event Date 12/12/2014

Event Type  Injury  

Event Description

It was reported that there was infection (unknown type of infection) at the pocket site of the patient¿s implantable neurostimulator (ins) along with tenderness at the lead incision site.Patient symptoms of incisional wound opening, drainage, pain, redness, sweating (diaphoresis), and swelling at the device pocket and lead location sites was noted.Diagnostics and troubleshooting performed included impedance testing and x-rays (no results reported).It was reported that antibiotic treatment was necessary for the event issues.The ins and lead were explanted on (b)(6) 2014 and the sites washed and closed using sterile procedure.No further details, interventions, or an outcome were reported regarding this event.Additional information could not be obtained at the time of the report.Should additional information be received a supplemental report will be filed.

Event Description

It was reported that perioperative antibiotics were administered.The date of onset or diagnosis of infection was unclear as it was noted to be on ¿(b)(6) 2015.¿ it was reported that the patient did not have meningitis.A culture was taken from the device pocket where the type of organism cultured was reported to be ¿none.¿ oral antibiotics and total device system explant were instituted for the infection and the outcome of the infection was reported to be resolved.Other information of importance was reported obesity.

Manufacturer Narrative

Concomitant medical products: product id 39286-65, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: lead; product id 97754, serial# (b)(4), product type: recharger; product id 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• 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 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: 4433328
• MDR Text Key: 5385324
• Report Number: 3004209178-2015-00932
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2015
• Date Device Manufactured: 11/14/2014
• 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: 00044 YR