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

Model Number 97714

Device Problem Malposition of Device (2616)

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

Event Date 04/27/2016

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with a neurostimulator for spinal pain.It was reported that the patient just had an implantable neurostimulator revision on (b)(6) 2016 because the implantable neurostimulator was too close to the spine and was touching the spine.The manufacturer representative reported that the patient has gained a significant amount of weight since implant and the manufacturer representative and health care provider were working with her to find a solution that works.The implantable neurostimulator was originally implanted on (b)(6) 2016.

Manufacturer Narrative

See manufacturer¿s reports 3004209178-2014-09503 and 3004209178-2016-18758 for the patient¿s other issues.

Event Description

Additional information received from the patient reported that they had over 7 different surgeries and not able to have adequate therapy (through adjustments) related to their implanted devices.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5941074
• MDR Text Key: 54395333
• Report Number: 3004209178-2016-18667
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/13/2017

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: 02/28/2017
• 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: 08/19/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/11/2017
• Supplement Dates FDA Received: 09/09/2016; 01/13/2017; 09/25/2017
• Date Device Manufactured: 04/06/2016
• 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: 34 YR