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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Malposition of Device (2616); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported that the patient stated her leads were never hooked up.The patient never had therapeutic effect.The patient had tried to start charging in (b)(6) 2014, but she was never able to do so.An overdischarge (od) was suspected.The patient had changed physicians and may have a revision.Additional follow up from the company representative stated that at the time of implant, he was aware that only one lead was implanted when the original plan was 2.They physician had difficulty placing the lead due to the patient having ¿too much tissue between the skin and spinal cord.¿ the patient was unhappy and lost confidence in the physician.The patient was not happy with the therapy.The company representative had checked the devices and said they were fine, but due to non-optimal placement of the lead (and absence of the second lead) the patient was just not getting optimal relief.The implanting physician had offered a revision but the patient declined.The patient initially stated that she would leave the device off as she had trips planned.Additional information indicated that the patient had the device replaced as the lead had migrated.The patient had stimulation in her ribs/lungs.The implant had been done by another surgeon, and the current surgeon wanted to replace the whole system.The patient was scheduled to return for follow up on (b)(6) 2014 but it was stated that both the leads and the battery were replaced successfully with good therapeutic coverage post operatively.

Manufacturer Narrative

Concomitant products: product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type lead; product id 97740, serial # (b)(4), product type programmer, patient; product id 97754, serial # (b)(4), product type recharger; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead.(b)(4).

• 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: 4262625
• MDR Text Key: 5047460
• Report Number: 3004209178-2014-21887
• 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
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2014
• Date Device Manufactured: 02/03/2014
• 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: 00062 YR