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

Model Number 97714

Device Problem Device Difficult to Program or Calibrate (1496)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 10/31/2014

Event Type  malfunction  

Event Description

The patient noticed approximately two months that the stimulation was not reaching her right foot like it should.Some reprogramming was performed on (b)(6) 2014, and since then the patient has been experiencing ¿zinging¿ shocking ¿out of the blue¿ where her legs go out from under her.The ¿zinging¿ occurred since reprogramming so the next day the patient turned the implantable neurostimulator (ins) off; she does not get shocked with it off.The patient also reported being ¿zapped¿ out of the blue several times while sleeping and standing.The patient was told to keep it on program a only and she did what she was told with the settings, but she was still getting shocked.An information request was made regarding the patient programmer (pp).On (b)(6) 2014, the patient needed to be reprogrammed again because the adaptivestim was not programmed correctly.A week later the patient went to the office and the physician turned the adaptivestim off.Additional information has been requested to find out if any intervention or troubleshooting was required and to obtain the outcome of this event.If additional information is received, a follow up will be sent.

Manufacturer Narrative

Concomitant products: product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 3550-29, lot# n457659, implanted: (b)(6) 2014, product type: accessory.(b)(4).

• 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 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: 4255626
• MDR Text Key: 16781096
• Report Number: 3004209178-2014-21688
• 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
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2014
• Date Device Manufactured: 03/05/2014
• 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: 00054 YR