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

Model Number 97714

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

Patient Problem Seroma (2069)

Event Type  Injury  

Event Description

It was reported that the patient had undergone a revision as the stimulator was uncomfortable for the patient and the skin was thinning on top of the generator.During the procedure, there was cloudy fluid noticed at the pocket site.The physician requested a gram stain of the fluid and it came back with increased white blood cells.After consulting with another physician, it was decided the safest route for the patient was to do an entire system explant (leads and stimulator) and have the patient complete a round of antibiotics.The system itself was sent in for a culture by the surgery center.The patient was doing fine and recovering from the procedure (and not receiving therapy as the system was explanted).

Manufacturer Narrative

Concomitant medical products: product id 97754, serial# (b)(4), product type: recharger; product id 97740, serial# (b)(4), product type: programmer, patient; product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• 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: 4443258
• MDR Text Key: 20756626
• Report Number: 3004209178-2015-01103
• 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
• Report Date: 12/31/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2014
• Initial Date FDA Received: 01/22/2015
• Date Device Manufactured: 10/24/2013
• 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): Required Intervention
• Patient Age: 00054 YR