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); Device Or Device Fragments Location Unknown (2590)

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

Event Type  Injury  

Event Description

It was further stated that the patient was to return to the office on (b)(6) 2014 to evaluate her status for a possible implant of a laminectomy lead.If additional information is received a follow up report will be sent.

Event Description

A few months later it was reported that the patient had a lami lead implanted on (b)(6) 2014.The device was reprogrammed on (b)(6) 2014 and patient was satisfied with stimulation coverage.Patient¿s incisions were healing well, no infection noted.No follow-up needed in future.The patient will contact the device manufacturer as needed.

Manufacturer Narrative

Concomitant products: product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type lead; product id neu_ptm_prog, serial # unknown, product type programmer, patient.(b)(4).

Event Description

The left lead migrated anterior and caused pain that went down the left leg.The right lead stimulated the buttocks and leg, did not reach back.Device reprogramming was attempted and a ct-scan was performed.The patient also never had therapeutic effect.The leads were explanted from the epidural space.There was a cut at the incision at the back to leave the pocket incision intact to reduce the chance of infection.It was noted that the leads were partially explanted.The plan was to implant a paddle lead at a later date.The patient was alive with no injury.Additional information has been requested.

• 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 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: 3947387
• MDR Text Key: 4723163
• Report Number: 3004209178-2014-13295
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2014
• Date Device Manufactured: 02/13/2014
• 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: 00059 YR