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

Model Number 97702

Device Problems Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/26/2014

Event Type  Injury  

Event Description

It was reported that the patient implanted with their implantable neurostimulator (ins) and post-op programming was performed.The patient felt therapy in the appropriate area.The patient then got dressed and when they tried to turn up the therapy they could not feel it, even when the voltage was at maximum.The manufacturer¿s representative tested ¿up and down¿ the lead component of the ins but could not get a response from the patient.Diagnostics of impedance testing and reprogramming was performed.It was noted that there was a couple of times where the patient thought they felt ¿something¿ at the incision site.It was reported that the patient experienced a loss of stimulation and therapeutic effect at the lead location.The patient¿s physician was notified and it was decided, at this point, to have the patient turned the device off, wait a couple of days, re-test, and then decide what to do.It was reported that reprogramming of the patient was to be tried again and that x-rays will be taken on (b)(6) 2014 at which time further actions will be decided after that.Additional information was requested but was not available at the time of this report.If additional information is received, a follow up report will be sent.

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: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that fluoroscopy was done after several days after the procedure and the leads had backed out of the epidural space.It was noted that the patient had good coverage before she got dressed so it was unknown what had happened "but it seemed it happened when she got dressed." it was noted that the anchors were still intact and holding from what they found during the lead revision.It was also reported that the patient called the manufacturer's representative "yesterday" and was doing very good.If additional information is received, a supplemental report will be filed.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 3753943
• MDR Text Key: 4470509
• Report Number: 3004209178-2014-07333
• 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
• Report Date: 03/26/2014

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: 06/14/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 04/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/22/2014; 05/22/2014
• Date Device Manufactured: 12/19/2013
• 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: 00073 YR