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

Model Number 97712

Device Problems Intermittent Continuity (1121); Failure to Interrogate (1332); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problems Swelling (2091); Ulcer (2274); Discomfort (2330); Electric Shock (2554)

Event Date 11/01/2016

Event Type  malfunction  

Event Description

Information was received from the consumer regarding a patient implanted with a neurostimulator for spinal pain.It was reported that stimulation from their implantable neurostimulator (ins) seemed to increase and was zapping them on its own.The patient noted that they were hanging plastic in a back room when their foot got tangled, missed the last step on the step-stool ladder.They fell on to a box with soft stuff in and the ins ¿really started to zap¿ them.The patient contacted the manufacturer¿s representative where they were instructed on how to turn the stimulation off with the recharger.The patient was going to follow up with their healthcare professional (hcp) and had an appointment scheduled for (b)(6) 2016.

Event Description

Additional information was received from the patient.It was reported that the manufacturer representative was unable to connect to the ins because the ins battery had depleted.The patient reported that the ins depleted faster than usual since their fall in 2016.The patient reported tenderness at the ins site over the incision.It was reported that the patient felt the stimulation to be strong and then not as strong at times.The patient was also having sores on their legs and was feeling like they were getting a"zap" in that area.The patient also reported a swollen ankle.It was reported that the patient was experiencing bilateral stimulation in the back, leg, and hip.All of the symptoms mentioned above started in (b)(6) 2016.The patient had had the device reprogrammed on (b)(6) 2017.No further complications are anticipated.

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: 6181273
• MDR Text Key: 62678896
• Report Number: 3004209178-2016-26624
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2017
• Date Device Manufactured: 08/08/2016
• 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 Age: 59 YR