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

Model Number 97714

Device Problems Battery Problem (2885); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 977a2, product type: lead.Product id: 977a2, product type: lead.

Event Description

Information was received from a manufacturing representative (rep) regarding a patient who was implanted with an implantable neurost imulator (ins).It was reported the patient's device was removed because they had not received pain relief and had a loss of efficacy in addition to the fact that they were moving and would be two hours from their doctor.Reprogramming had been attempted.The ex planted devices (ins and two leads) were returned to medtronic for disposal.No further complications were reported or anticipated.

Manufacturer Narrative

The patient and device codes have been updated.

Event Description

Information was received from a healthcare professional of a clinical study regarding a patient with an implantable neurostimulator (ins) for failed back surgerysyndrome.Device interrogation and device data on (b)(6) 2016 determined the battery discharged.The ins was unable to recharge.The therapy was suspended on (b)(6) 2016.The event was related to the device or therapy, specifically the patient's non-compliance as the patient forgot to recharge.The ins was explanted on (b)(6) 2017 because the primary indication for the device use went away and the patient improved.No further patient complication was reported as a result of the event.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis determined the ins was at reduced capacity due to over discharge.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6500376
• MDR Text Key: 73032769
• Report Number: 3004209178-2017-08495
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/29/2017

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: 09/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 06/29/2017
• Supplement Dates FDA Received: 05/11/2017; 05/17/2017; 06/20/2017; 06/29/2017; 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• 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: 66 YR
• Patient Weight: 98