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

Model Number 97714

Device Problems Unstable (1667); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - spinal pain.It was reported that it was difficult to recharge.Representative (rep) reported that the patient had difficulty with getting coupling.Patient generally got 2 coupling bars and if rep pushed against the neurostimulator (ins) then patient got 4 bars, but that could change with movement.Al feature showed baseline of 32 and the highest was 38.Discussed pocket site, rep stated the inferior part of the implant was perpendicular to the body.Tech services reviewed with the rep since device was getting 4 bars at times, especially when recharger (insr) is pushing the ins flat, it's not likely the implant being flipped, although imaging could confirm.Tech services reviewed it was likely the ins being at an angle and causing coupling issues.It was reported that the most recent issue with coupling and the ins perpendicular to body occurred 2-3 weeks ago.Rep was redirected to healthcare provider to determine further action.No symptoms reported.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received.It was reported that the caller reported he was seeing his patient for possible assessment of a flipped device.Caller reported patient would get 4 coupling bars and than dropped to 2 coupling bars.Caller reported he has tried all possible troubleshooting to obtain the coupling bar, different recharger, recharging belt, and adhesive disc.Caller reported the pocket appears to be deeper and loose.Caller reported he could feel the outline but the ins is moving in the pocket and dives down when the recharger is placed on the device.It was reported that the pocket was too deep.

Manufacturer Narrative

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

Event Description

Additional information was received from a representative.It was reported that the patient will be getting their device replaced with a non-rechargeable ipg.It was reported about 2 weeks ago recharging efforts were unsuccessful.It was reported that the patient's body anatomy caused the ipg to deep making the angle of recharging impossible.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 7150764
• MDR Text Key: 96124307
• Report Number: 3004209178-2017-26706
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2018
• Date Device Manufactured: 08/30/2017
• 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: 74 YR