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

Model Number 97714

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 977a275, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2015, 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

A consumer via a manufacturer representative reported the latest implant was ineffective and there was possible lead migration.No factors were known to have led to the event.Multiple reprograms were done without success and x-rays had been taken.An explant was planned for (b)(6) 2016.Information received from a representative reported the consumer was notified that the surgery was cancelled because it had not been approved.The consumer noted being in pain and was directed to contact the doctor's office.Indication for use included non-malignant pain.

Manufacturer Narrative

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

Additional information received from the rep reported that the patient underwent revision surgery a week and a half prior to date of additional information on 2016-jun-29.The rep had not heard back from the patient yet and will update as more information comes in.

Event Description

Additional information received from the patient reported that his percutaneous lead was replaced with a paddle lead on (b)(6) 2016 because ¿it was not capturing.¿ the revision had occurred and the patient had completely recovered.

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: 5748888
• MDR Text Key: 48149256
• Report Number: 3004209178-2016-12888
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Date Device Manufactured: 07/21/2015
• 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: 47 YR