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

Model Number 97702

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429)

Patient Problems Abdominal Pain (1685); Pain (1994)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a160, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2016, product type: lead.

Event Description

The healthcare professional (hcp) of a clinical study reported that there was lead migration/dislodgement.The clinical diagnosis was left flank and abdominal pain when the stimulator was on, and no left leg pain relief.The outcome was ongoing.Interventions included explanting and replacing the lead.The event resulted in an unscheduled clinic or office visit.Imaging showed abnormal that the left lead migrated laterally and anteriorly.The etiology was noted as related to the device or therapy and not related to the procedure.The etiology was noted as related to the lead which was connected to the implantable neurostimulator (ins).The patient had fallen 3 times since (b)(6) 2015.Relevant medical history included: spinal pain.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that the etiology was noted as related to the device or therapy and not related to the implant procedure.The etiology was noted as related to both leads which were both connected to the implantable neurostimulator (ins).

Event Description

Additional information received reported the event resolved without sequelae on (b)(6) 2016.

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: 5555092
• MDR Text Key: 42089935
• Report Number: 3004209178-2016-06323
• 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,Followup
• Report Date: 09/20/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/29/2016
• Supplement Dates FDA Received: 04/28/2016; 09/20/2016; 09/21/2017
• Date Device Manufactured: 09/09/2014
• 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: 00078 YR