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 Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 12/21/2016

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id 977a260 lot# serial# (b)(4) implanted: (b)(6) 2016 explanted: product type lead product id 977a260 lot# serial# (b)(4) implanted: (b)(6) 2016 explanted: product type lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received regarding a patient¿s implantable pulse generator (ipg) implanted for failed back surgery syndrome as well as spinal pain.Manufacturer representative reported the patient developed an infection at the ipg site.It was reported that the patient was on two different antibiotics post operation and that the incision never healed well.The patient¿s ipg and leads were explanted.The issue was reportedly resolved.

Event Description

Additional information was received from the manufacturer representative.It was reported that they were notified of the infection on (b)(6) 2017 and the incision had been looking worse over the couple weeks prior.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6234116
• MDR Text Key: 64212956
• Report Number: 3004209178-2017-00489
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2017

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: 09/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2017
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided; 01/05/2017
• Supplement Dates FDA Received: 01/17/2017; 09/28/2017
• Date Device Manufactured: 10/26/2016
• 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: 54 YR