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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Device Difficult to Program or Calibrate (1496); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Event Description

The patient experienced a shocking or jolting sensation.The patient was reprogrammed this past wednesday.Since the reprogramming, the stimulation has been turning on/off by itself.The adaptive stim (as) was all reset to a different setting.The as did not recognized the new setting, has gone back to old setting, even after the 3 minute timer.When the patient was lying on her back, she decreased her stimulation to 0v, set her phone timer to 3 minutes, raised and bent her leg.After the 3 minutes, the device went up to 1.70v and it was displaying lying on her back.At that time the patient felt jolting from her stimulation.The ins was not recognizing the last setting she programmed with her patient programmer.The only position the ins displayed was lying on her back, no matter what position the patient was in.The ins pocket did not seem loose nor did it seem like the device was moving around.The company representative palpated the ins pocket and it did not seem loose to him.The physician programmer (8840) displayed the following: lying on back when in a sitting position, lying on back when lying on right side, lying on back when lying on back.Additional information has been requested.

Manufacturer Narrative

Concomitant medical products: product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.(b)(4).

Event Description

It was later reported that the patient¿s device was reoriented and the shocking sensation was eliminated.

• 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: 3869701
• MDR Text Key: 4512371
• Report Number: 3004209178-2014-11479
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2014

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: 06/14/2014
• 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: 06/11/2014
• Initial Date FDA Received: 06/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/18/2014
• Date Device Manufactured: 07/20/2013
• 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 Age: 00040 YR