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); Unspecified Infection (1930); Pain (1994); Impaired Healing (2378)

Event Date 08/03/2015

Event Type  Injury  

Event Description

The healthcare professional (hcp) of a clinical study reported that the clinical diagnosis was implantable neurostimulator (ins) site infection.The left upper buttock incision was not healing well.The wound was open and draining.The patient reported ins site pain.The outcome was resolved without sequelae.Interventions included surgical intervention.The event resulted in an unscheduled clinic or office visit.The etiology was noted as related to the implantable neurostimulator (ins) pocket.Relevant medical history included: spinal pain.

Event Description

Additional information received reported actions included re-anchoring, wound revision, and cultures of the ins on (b)(6) 2015.The etiology was updated to unlikely related to device or therapy and possibly related to the procedure.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5917751
• MDR Text Key: 53593121
• Report Number: 3004209178-2016-17988
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2016

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: 05/14/2016
• 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: 08/12/2016
• Initial Date FDA Received: 08/31/2016
• Supplement Dates Manufacturer Received: Not provided; 11/21/2016
• Supplement Dates FDA Received: 12/13/2016; 09/25/2017
• Date Device Manufactured: 06/18/2015
• 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: 49 YR