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

Model Number 97714

Device Problems Intermittent Continuity (1121); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 12/13/2013

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, 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 reported that lately a patient¿s therapy was ¿cutting out and starting up again and cutting out¿.It was reported that it started last month.It was reported he had a shocking/jolting sensation, and described ¿sharp shocks¿ near the battery and ¿electrocuted pain,¿ which started in the last month, same as cutting out.Additional information received reported that the cause of the event was that the ¿sensor needed reorientation¿.It was reported that all impedances were within normal range.It was reported that the patient was reprogrammed and the sensor was reoriented on the date of this report.It was reported that the patient tested out all positions.It was reported that the patient was satisfied with the results.It was stated that the cutting out and shocking were resolved by sensor reorientation.

• 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: 3600755
• MDR Text Key: 19322904
• Report Number: 3004209178-2014-01416
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2014

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: 01/13/2014
• Initial Date FDA Received: 01/30/2014
• Date Device Manufactured: 07/16/2013
• 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: 00037 YR