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); High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2014

Event Type  Injury  

Event Description

It was reported that after implantable neurostimulator replacement for an unknown reason, the patient was seen at a post-operative appointment on (b)(6) 2014 and there was no stimulation with all electrodes having high impedances >10000 ohm.It was noted that the patient will return to surgery, where lead and extensions will be tested on the table and replacement will be done as indicated.As of (b)(6) 2014, surgery had yet to be scheduled.It was reported that the patient was alive with no injury.Additional details and outcome were not reported, follow-up is being conducted to obtain this information.If additional information is received a follow-up report will be sent.See mfr 3004209178-2014-18078 for impedance issue with the patient's prior device.

Manufacturer Narrative

Concomitant products: product id: 3708140, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 39565-30, serial# (b)(4), implanted: (b)(6) 2008, product type: lead.Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 37712, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2014, product type: implantable neurostimulator.(b)(4).

Event Description

It was further reported that the revision had been scheduled for (b)(6) 2014 but was cancelled and rescheduled for (b)(6) 2014.Add itional information about the details of the revision and the outcome were requested, if received, a follow up report will be sent.

Event Description

It was further stated that the stimulator depletion was normal as she used the system 24/7.

Event Description

It was further reported that the revision surgery occurred on (b)(6) 2014.The extensions were disconnected from the stimulator and cleaned, as well as the ports.Impedances were normal except for electrode 10.Coverage was appropriate.

• 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: 4132579
• MDR Text Key: 4939297
• Report Number: 3004209178-2014-18082
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2014
• Date Device Manufactured: 07/17/2014
• 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: 00055 YR