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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Improper or Incorrect Procedure or Method (2017); Low Battery (2584)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

The implant was not working at all and the patient did not feel any stimulation.The patient has never charged the implant since she got it put in, she needed assistance charging.How to charge was reviewed.The patient was going to charge and once the implant is charged and on she was going to call back for further assistance.The patient felt that she needed to make adjustments in programming.Additional information has been requested.

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97754, serial# (b)(4), product type: recharger.(b)(4).

Event Description

Additional information was received from the consumer.It was reported that the patient had an appointment scheduled for (b)(6) 2016-aug-04 with their healthcare provider (hcp) to discuss ins overdischarge needs and next steps.Follow-up has been conducted to obtain this information.If additional information is received, a follow-up report will be sent.

• 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: 3944907
• MDR Text Key: 4641720
• Report Number: 3004209178-2014-13268
• 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,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2016

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: 01/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2014
• Initial Date FDA Received: 07/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2016
• Date Device Manufactured: 03/05/2014
• 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 Age: 00067 YR